Trial Outcomes & Findings for High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma (NCT NCT01124734)
NCT ID: NCT01124734
Last Updated: 2019-02-12
Results Overview
Clinical response was measured using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria categorizing responses as complete response (CR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
2 years
Results posted on
2019-02-12
Participant Flow
This was a single center study conducted at Penn State Hershey Medical Center Cancer Institute. The study was carried out in the Cancer Institute outpatient clinic. Accrual was initiated 9/07/2011 and completed completed 04/28/2014. Participants remained on study for long term follow up. The study closed in July 2018.
Participants were excluded if they received any chemotherapy, hormonal therapy, immunotherapy, or radiation therapy within 1 month of entry to the study.
Participant milestones
| Measure |
Course 1 Cycle 1 and Cycle 2
This study is a single arm study. All participants received the same treatment regimen.
For initiation of study intervention (Course 1 - Cycle 1) participants are admitted inpatient for Course 1 Cycle 1 of HD IL-2 treatment. Participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. Participants will be discharged when the acute toxicities of the IL-2 have subsided.
Course 1 Cycle 2: After discharge, participants will be reassessed on or about 10 days after discharge (D10) and will be re-admitted to initiate Course 1 Cycle 2. For this Cycle 2, participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. After completion of this cycle 2 HD IL-2, they would begin Temzolomide at 75 mg/m2 on the day after hospital discharge. Participants will continue with Temzolomide for a total of 21 days.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Completion of Course 1 Cycle 1
|
17
|
|
Overall Study
Initiation of Course 1 Cycle 2
|
17
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Course 1 Cycle 1 and Cycle 2
This study is a single arm study. All participants received the same treatment regimen.
For initiation of study intervention (Course 1 - Cycle 1) participants are admitted inpatient for Course 1 Cycle 1 of HD IL-2 treatment. Participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. Participants will be discharged when the acute toxicities of the IL-2 have subsided.
Course 1 Cycle 2: After discharge, participants will be reassessed on or about 10 days after discharge (D10) and will be re-admitted to initiate Course 1 Cycle 2. For this Cycle 2, participants will be given as many doses of IL-2 as tolerated up to a maximum of 14 at 8 hr intervals as allowed by the algorithm at 600,000 IU/kg. After completion of this cycle 2 HD IL-2, they would begin Temzolomide at 75 mg/m2 on the day after hospital discharge. Participants will continue with Temzolomide for a total of 21 days.
|
|---|---|
|
Overall Study
Disease progression
|
13
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Elected for alternative treatment
|
2
|
Baseline Characteristics
High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma
Baseline characteristics by cohort
| Measure |
Course 1 Cycles 1 and 2
n=17 Participants
Course 1 Cycles of Part 1: Participants will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
Course 2: Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days. Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg. Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsClinical response was measured using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria categorizing responses as complete response (CR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD).
Outcome measures
| Measure |
Course 1 Cycle 1
n=17 Participants
This study is a single arm study. All participants received the same treatment regimen.
Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
|
Course 1 Cycle 2
n=17 Participants
Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
|
|---|---|---|
|
Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide
Stable Disease
|
17 Participants
|
4 Participants
|
|
Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide
Partial Response
|
0 Participants
|
1 Participants
|
|
Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide
Progressive Disease
|
0 Participants
|
9 Participants
|
|
Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide
Minor Response
|
0 Participants
|
1 Participants
|
|
Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide
Complete Response
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 8 yearsPopulation: Duration of response is applicable for those CR/MR/PR/SD subjects only.
Duration of response is defined as the length (measured in days) from the date of best response to the date of progression (if any), or to the date of last follow-up (if no progression is observed). The duration of response is applicable for those CR/MR/PR/SD subjects only.
Outcome measures
| Measure |
Course 1 Cycle 1
n=8 Participants
This study is a single arm study. All participants received the same treatment regimen.
Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
|
Course 1 Cycle 2
Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
|
|---|---|---|
|
Duration of Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide
|
432.88 Days
Interval 0.0 to 963.16
|
—
|
PRIMARY outcome
Timeframe: 2 yearsSafety and toxicity in this study population was evaluated using the NCI Common Toxicity Criteria. The unit of measure is the number of study participants with one or more unexpected and related (even remotely) SAE.
Outcome measures
| Measure |
Course 1 Cycle 1
n=17 Participants
This study is a single arm study. All participants received the same treatment regimen.
Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
|
Course 1 Cycle 2
n=17 Participants
Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
|
|---|---|---|
|
Safety and Toxicity of H-D IL-2 Followed by Low Dose Temozolomide
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Of the 17 qualifying participants, 9 underwent baseline (pre-Course 1) testing. Eleven participants consented to and underwent this POST off- treatment testing. Two of the participants tested at Post treatment did not have baseline testing done.
The effect outcome is measured by the change in percentage of circulating lymphocyte cells (autoimmune biomarkers) that express the noted phenotype. This percentage change is determined by comparing the values obtained within 7 days of participant going off treatment against the baseline values.
Outcome measures
| Measure |
Course 1 Cycle 1
n=9 Participants
This study is a single arm study. All participants received the same treatment regimen.
Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
|
Course 1 Cycle 2
n=11 Participants
Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
|
|---|---|---|
|
Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers)
%CCR7- CD45RO+ of CD4+ Effector Memory
|
.36 Percentage of Cells
Standard Deviation .10
|
.36 Percentage of Cells
Standard Deviation .10
|
|
Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers)
%CCR7- CD45RO+ of CD8+ Effector Memory
|
.31 Percentage of Cells
Standard Deviation .10
|
.34 Percentage of Cells
Standard Deviation .16
|
|
Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers)
%CCR7- CD45RO- of CD4+ Effector Memory RA+
|
.09 Percentage of Cells
Standard Deviation .08
|
.08 Percentage of Cells
Standard Deviation .07
|
|
Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers)
%CCR7- CD45RO- of CD8+ Effector Memory RA+
|
.46 Percentage of Cells
Standard Deviation .18
|
.40 Percentage of Cells
Standard Deviation .15
|
|
Effect of High Dose IL2 Followed by Low Dose Temozolomide on Lymphocyte Subsets (Autoimmune Biomarkers)
%CD25+FoxP3+ of CD4+ (Tregs)
|
.10 Percentage of Cells
Standard Deviation .05
|
.09 Percentage of Cells
Standard Deviation .05
|
Adverse Events
Course 1 Cycle 1
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Course 1 Cycle 2
Serious events: 1 serious events
Other events: 17 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Course 1 Cycle 1
n=17 participants at risk
This study is a single arm study. All participants received the same treatment regimen.
Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
|
Course 1 Cycle 2
n=17 participants at risk
Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 1 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Cardiac disorders
Arrhythmia
|
5.9%
1/17 • Number of events 1 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
Other adverse events
| Measure |
Course 1 Cycle 1
n=17 participants at risk
This study is a single arm study. All participants received the same treatment regimen.
Participants were given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
|
Course 1 Cycle 2
n=17 participants at risk
Patients will be given High-Dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.
Interleukin-2: up to a maximum of 14 doses at 600,000 IU/kg
Temozolomide: Patients would receive temozolomide at 75 mg/m2 after discharge from receipt of the second cycle of high dose IL-2. Patients would take the medication at bedtime daily. Four weeks after cycle 2 of a course, they would take it for 21 days.
|
|---|---|---|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
35.3%
6/17 • Number of events 20 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Vascular disorders
Capillary leak syndrome
|
58.8%
10/17 • Number of events 18 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
23.5%
4/17 • Number of events 6 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Diarrhea
|
52.9%
9/17 • Number of events 24 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
23.5%
4/17 • Number of events 7 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Mucositis
|
35.3%
6/17 • Number of events 15 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
11.8%
2/17 • Number of events 4 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
General disorders
Flu like symptoms
|
52.9%
9/17 • Number of events 18 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 9 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
General disorders
Fatigue
|
52.9%
9/17 • Number of events 15 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Abdominal cramping
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Hepatobiliary disorders
Alkaline phosphatase increase
|
29.4%
5/17 • Number of events 8 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 1 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
35.3%
6/17 • Number of events 8 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Blood and lymphatic system disorders
Anemia
|
41.2%
7/17 • Number of events 17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 8 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Loss of Appetite - Anorexia
|
35.3%
6/17 • Number of events 10 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 3 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
23.5%
4/17 • Number of events 7 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Number of events 4 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Renal and urinary disorders
Increased creatinine
|
35.3%
6/17 • Number of events 11 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 7 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Nervous system disorders
Dizziness
|
17.6%
3/17 • Number of events 3 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
47.1%
8/17 • Number of events 8 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 3 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Dysgeusia
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.4%
5/17 • Number of events 10 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 1 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
23.5%
4/17 • Number of events 7 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
41.2%
7/17 • Number of events 15 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 10 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
52.9%
9/17 • Number of events 32 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 9 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.5%
4/17 • Number of events 7 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
11.8%
2/17 • Number of events 3 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
41.2%
7/17 • Number of events 14 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 6 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.3%
6/17 • Number of events 15 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 6 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
47.1%
8/17 • Number of events 18 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
23.5%
4/17 • Number of events 7 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Blood and lymphatic system disorders
INR increased
|
29.4%
5/17 • Number of events 9 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
23.5%
4/17 • Number of events 8 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 4 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • Number of events 17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 6 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.4%
5/17 • Number of events 7 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 1 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
17.6%
3/17 • Number of events 3 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Blood and lymphatic system disorders
Activated partial thromboplastin time prolonged
|
17.6%
3/17 • Number of events 4 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.6%
3/17 • Number of events 3 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
5.9%
1/17 • Number of events 1 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
11.8%
2/17 • Number of events 2 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Cardiac disorders
Supraventricular tachycardia
|
11.8%
2/17 • Number of events 3 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
52.9%
9/17 • Number of events 24 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 12 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Gastrointestinal disorders
Vomiting
|
41.2%
7/17 • Number of events 14 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
17.6%
3/17 • Number of events 6 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
17.6%
3/17 • Number of events 8 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
0.00%
0/17 • Participants were followed for all AEs (Grade 0-V) from enrollment (signing consent) to the day they were rendered off study. The follow up period was indefinite as when off treatment, all were followed for disease status. Total time period for those who remained on study until the end is 8 years.
Definition and processes the same as clinicaltrials.gov terminology.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place