Trial Outcomes & Findings for Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer (NCT NCT00887640)
NCT ID: NCT00887640
Last Updated: 2014-02-26
Results Overview
Median percent change in CTC count from baseline to 8 weeks of treatment. Percent change was calculated by determining the percentage increase or decrease in CTC count from baseline.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2014-02-26
Participant Flow
Participant milestones
| Measure |
Temsirolimus 25 mg
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
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|---|---|
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Overall Study
STARTED
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11
|
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Overall Study
COMPLETED
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11
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Temsirolimus 25 mg
n=11 Participants
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
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|---|---|
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Age, Continuous
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61 years
n=5 Participants
|
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Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: CTC count at both baseline and week 8 were assessable in 8 of the 11 patients as CTCs were collected at both time points in these patients. Missing CTC data for 3 of the 11 patients due to laboratory error or no CTC available at various time points.
Median percent change in CTC count from baseline to 8 weeks of treatment. Percent change was calculated by determining the percentage increase or decrease in CTC count from baseline.
Outcome measures
| Measure |
Temsirolimus 25 mg
n=8 Participants
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
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|---|---|
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Change in Circulating Tumor Cell (CTC) Counts in Men With Metastatic Treatment-refractory Castration-resistant Prostate Cancer.
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-20 percent change
Interval -53.0 to 73.0
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SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Data were insufficient to evaluate this outcome. Outcome not available at 12 weeks. CTCs were not collected at week 12 and thus were not analyzed.
To evaluate the change in CTC counts upon the addition of an anti-androgen upon PSA progression while on temsirolimus therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: N-cadherin expression at both baseline and 8 weeks was evaluable in 7 patients.
Measures of epithelial plasticity on CTCs in response to Mammalian Target of Rapamycin (mTOR) inhibition with temsirolimus, using genomic and protein immunohistochemical methodology. N-cadherin was measured in CTCs captured using the CellSearch profile kit. The proportion of CTCs expressing N-cadherin was calculated and divided by the total number of CD45-negative, pan cytokeratin (CK) - positive, and 4',6-diamidino-2-phenylindole (DAPI+) intact cells to give a fractional expression of N-cadherin. Results are reported as a percentage.
Outcome measures
| Measure |
Temsirolimus 25 mg
n=7 Participants
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
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|---|---|
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Mean Percent of N-cadherin Expression at Baseline and 8 Weeks of Treatment.
Expression at baseline
|
91 Percent expression
Interval 65.0 to 100.0
|
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Mean Percent of N-cadherin Expression at Baseline and 8 Weeks of Treatment.
Expression at 8 weeks
|
92 Percent expression
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.
To evaluate and correlate changes in serum Lactate Dehydrogenase (LDH) with CTC count changes over time in men with Castrate Resistant Prostate Cancer (CRPC) treated with temsirolimus
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTime in months from the start of study treatment to the date of first progression according to Prostate Cancer Clinical Trial Working Group 2 (PCWG2) criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Additionally, according to PCWG2 criteria, disease progression in bone is defined as 2 or more new lesions seen on bone scan compared with the baseline scan used for trial entry. Per PCWG2 guidelines, therapy was not discontinued solely due to a rise in PSA alone.
Outcome measures
| Measure |
Temsirolimus 25 mg
n=11 Participants
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
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|---|---|
|
Median Progression-Free Survival (PFS)
|
1.9 Months
Interval 0.9 to 3.1
|
SECONDARY outcome
Timeframe: Baseline to 7 monthsPercent change in PSA between baseline and the measurement time point where the largest change in PSA occurred. Note that a positive change (greater than 0) indicates an increase in PSA, and a negative change (less than 0) indicates a decrease.
Outcome measures
| Measure |
Temsirolimus 25 mg
n=11 Participants
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
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|---|---|
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Maximum Rate of Change of Prostate-Specific Antigen (PSA).
|
48 Percent change
Interval -32.0 to 954.0
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SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were insufficient to evaluate this outcome. Data not collected. PSA responses were not observed in this study and PSA progression dates would essentially be the same as the radiographic PFS dates.
Time in months from the start of study treatment to the date of first PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were insufficient to evaluate this outcome. Data not collected. Patients progressed radiographically before 2nd PSA progression occurred.
Time in months from the time of anti-androgen therapy to the date of second PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to second PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.
Percent change in CTC gene expression from baseline to 8 or 12 weeks of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTotal number of grade 3, 4, and 5 adverse events at least possibly related to temsirolimus therapy. Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to 4.0 for the purposes of reporting to ClinicalTrials.gov.
Outcome measures
| Measure |
Temsirolimus 25 mg
n=11 Participants
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
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|---|---|
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Safety and Tolerability of Temsirolimus
Grade 3 Adverse Events
|
28 Adverse Events
|
|
Safety and Tolerability of Temsirolimus
Grade 4 Adverse Events
|
2 Adverse Events
|
|
Safety and Tolerability of Temsirolimus
Grade 5 Adverse Events
|
0 Adverse Events
|
Adverse Events
Temsirolimus 25 mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temsirolimus 25 mg
n=11 participants at risk
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Lung infection- Pneumonia
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Stroke- Hemorrhagic
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary tract obstruction
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Vascular disorders - Subdural Hemorrhage
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Other adverse events
| Measure |
Temsirolimus 25 mg
n=11 participants at risk
Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
45.5%
5/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Night blindness
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Lip Swelling
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
36.4%
4/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
54.5%
6/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Chills
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema limbs
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
54.5%
6/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Pain
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Eye Infection
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infection - Picc Line
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Lung infection- Pneumonia
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Urinary Tract Infection
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Bruising
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alkaline phosphatase increased
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Creatinine increased
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
INR increased
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Investigations - Fluid Overload
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Neutrophil count decreased
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Platelet count decreased
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight Loss
|
54.5%
6/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
63.6%
7/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypoalbuminenima
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypocalcinemia
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypokalemia
|
36.4%
4/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hyponaturemia
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain - Lower Extremities Bilateral
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain, Intermittant- Lower Left Quadrant
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Bilateral Jaw
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Bone
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Left Femur
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Left Hip / Low Back
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Left Hip / Thigh
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Left Shoulder
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Left Side
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Right Flank
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- Right jaw
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain- left flank area
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive Disturbance
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysgeusia
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders - Nightmares
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders- Restless Legs
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Confusion
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
27.3%
3/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Hematuria
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Renal and urinary disorders - Right hydonephrosis
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary frequency
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
45.5%
5/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
18.2%
2/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash - Groin
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash - Right Arm and Leg
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash- Ankles
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash- Penis
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Thromboembolic event- Pulmonary Embolism
|
9.1%
1/11 • 2 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place