Trial Outcomes & Findings for Pazopanib Hydrochloride Followed by Chemotherapy and Surgery in Treating Patients With Soft Tissue Sarcoma (NCT NCT01446809)
NCT ID: NCT01446809
Last Updated: 2020-04-13
Results Overview
Change in maximum SUV (standardized uptake value) of tumors measured by FDG-PET. Comparison conducted using a two-sided Wilcoxon rank sum test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
From baseline to 15 days
Results posted on
2020-04-13
Participant Flow
Participant milestones
| Measure |
Pazopanib
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
Blinded
Patients receive pazopanib hydrochloride or placebo PO QD. Patient did not complete study and thus treatment arm remains blinded.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
2
|
|
Overall Study
COMPLETED
|
14
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Pazopanib
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
Blinded
Patients receive pazopanib hydrochloride or placebo PO QD. Patient did not complete study and thus treatment arm remains blinded.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Failure to complete study procedures
|
0
|
0
|
1
|
Baseline Characteristics
Pazopanib Hydrochloride Followed by Chemotherapy and Surgery in Treating Patients With Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
n=93 Participants
|
61 years
n=4 Participants
|
53 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Screening SUV
|
7.1 Standardized Uptake Value- SUV
n=93 Participants
|
9.9 Standardized Uptake Value- SUV
n=4 Participants
|
8.3 Standardized Uptake Value- SUV
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to 15 daysChange in maximum SUV (standardized uptake value) of tumors measured by FDG-PET. Comparison conducted using a two-sided Wilcoxon rank sum test.
Outcome measures
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Change in Maximum SUV of Tumors Measured by FDG-PET Pre- and Post Receipt of Pazopanib Versus Placebo
|
-0.1 Standardized uptake value-SUV
Interval -14.7 to 3.5
|
-0.1 Standardized uptake value-SUV
Interval -2.2 to 6.0
|
PRIMARY outcome
Timeframe: From baseline to 8 weeksPopulation: 8 week PET not done on one Pazopanib participant.
Change in maximum SUV of tumors measured by FDG-PET. Comparison conducted using a two-sided Wilcoxon rank sum test.
Outcome measures
| Measure |
Pazopanib
n=13 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Change in Maximum SUV of Tumors Measured by FDG-PET Post Receipt of 2 Courses of Preoperative Chemotherapy
|
-1.1 SUV
Interval -32.7 to 5.0
|
-4.0 SUV
Interval -11.2 to -0.3
|
PRIMARY outcome
Timeframe: At 15 daysPopulation: Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the LD of target lesions; Progression (PD),20% increase in the sum of the LD of target lesions,or measurable increase in a non-target lesion,or appearance of new lesions.",
RECIST measurements will be performed on serial MRIs to evaluate the correlation with FDG-PET. The longest diameter (LD) of the target lesions will be measured and reported as the baseline LD. The baseline LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression (PD), 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
Outcome measures
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Tumor Response by RECIST Criteria
Stable Disease
|
14 Participants
|
6 Participants
|
|
Tumor Response by RECIST Criteria
Progressive Disease
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At 8 weeksPopulation: 8 week MRI not done on one Placebo patient.
RECIST measurements will be performed on serial MRIs to evaluate the correlation with FDG-PET. The longest diameter (LD) of the target lesions will be measured and reported as the baseline LD. The baseline LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression (PD), 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
Outcome measures
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=6 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Tumor Response by RECIST Criteria
Stable Disease
|
11 Participants
|
5 Participants
|
|
Tumor Response by RECIST Criteria
Progressive Disease
|
2 Participants
|
0 Participants
|
|
Tumor Response by RECIST Criteria
Partial Response
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysTrough plasma pazopanib concentration measured during the 14 day run-in period on days 10 through 14.
Outcome measures
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Pharmacokinetic Profile of Pazopanib
|
56.38 ng/mL
Standard Deviation 0.94
|
0 ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At baseline and after 14 daysPlasma will be collected for measurement of VEGF and soluble VEGFR2 (sVEGFR2) at baseline, after the 14 day Run-in period of pazopanib, after completion of neoadjuvant chemotherapy and approximately every 3 months thereafter until completion of pazopanib maintenance therapy, when indicated. Quantitative enzyme-linked immunosorbent assays (ELISA) for VEGF and sVEGFR2 will be performed on plasma and tumor extracts. Plasma will also be collected for micro RNA at baseline, after the 14 day Run-in period of pazopanib, following neoadjuvant chemotherapy and every 3 months thereafter until completion of pazopanib maintenance therapy, when indicated.
Outcome measures
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Change in Levels of VEGF and Soluble VEGFR2 Assessed by ELISA on Plasma and Tumor Extracts
|
NA percentage of concentration
PI left institution and this data was not analyzed.
|
NA percentage of concentration
PI left institution and this data was not analyzed.
|
SECONDARY outcome
Timeframe: Up to 3 yearsDefined as the interval of time from randomization until death from any cause.
Outcome measures
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Overall Survival
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: An expected average of 12 weeksEstimate the amount of viable tumor, and report the percentage of necrosis. Analysis was only completed on a subset of participants.
Outcome measures
| Measure |
Pazopanib
n=6 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=6 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Number of Participants With Pathologic Response at the Time of Surgery as Measured by % Tumor Viability ( >= 95% Necrosis)
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsDefined as the duration of time from randomization to progressive disease (per RECIST), local recurrence, distant metastatic disease (exclusive of stage IV subjects), or death, whichever occurs first.
Outcome measures
| Measure |
Pazopanib
n=14 Participants
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 Participants
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
|---|---|---|
|
Progression Free Survival
|
10 Participants
|
4 Participants
|
Adverse Events
Pazopanib
Serious events: 9 serious events
Other events: 0 other events
Deaths: 2 deaths
Placebo
Serious events: 4 serious events
Other events: 0 other events
Deaths: 3 deaths
Blinded
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pazopanib
n=14 participants at risk
Patients receive pazopanib hydrochloride PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib Hydrochloride: Given PO Pharmacological Study: Correlative studies Therapeutic Conventional Surgery: Undergo surgery
|
Placebo
n=7 participants at risk
Patients receive placebo PO QD. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.
Doxorubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo external beam radiation therapy Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO Therapeutic Conventional Surgery: Undergo surgery
|
Blinded
n=2 participants at risk
Patients receive pazopanib hydrochloride or placebo PO QD. Patient did not complete study and thus treatment arm remains blinded.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
14.3%
2/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
21.4%
3/14 • 3 years
|
57.1%
4/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Alanine Aminotransferase increased
|
7.1%
1/14 • 3 years
|
0.00%
0/7 • 3 years
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Catheter related infection
|
7.1%
1/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Platelet count decreased
|
28.6%
4/14 • 3 years
|
14.3%
1/7 • 3 years
|
50.0%
1/2 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • 3 years
|
0.00%
0/7 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Neutrophil count decreased
|
35.7%
5/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
White blood cell decreased
|
14.3%
2/14 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
7.1%
1/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/14 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pulmonary emboli
|
7.1%
1/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
|
Cardiac disorders
Endocarditis
|
0.00%
0/14 • 3 years
|
0.00%
0/7 • 3 years
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Left gluteal abscess
|
7.1%
1/14 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/2 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place