Prostate Cancer
Conditions
Keywords
Diagnostic, Imaging, 2301, PET/CT, PyL, PSMA, radical prostatectomy, metastatic prostate cancer, recurrent prostate cancer
Brief summary
This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B). Cohort B is complete and no longer recruiting subjects.
Interventions
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
DIAGNOSTIC_TESTPET/CT imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection
Sponsors
Progenics Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed adenocarcinoma of the prostate. 2. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. Cohort A Only: * At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA \>20 ng/mL or Gleason score ≥8). * Scheduled or planned radical prostatectomy with PLND. Cohort B Only: \[Enrollment is complete; No longer recruiting subjects\] * Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment. * If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed. * Scheduled or planned percutaneous biopsy of at least one amenable lesion.
Exclusion criteria
1. Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection. 2. Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. Cohort A Only: * Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention Cohort B Only: \[Enrollment is Complete; No longer recruiting subjects\] * Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed * Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. | The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint. |
| Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. | The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Changes in ECG pre-drug dosing and within 1-2 hours post-dosing | — |
| Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. | — |
| Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. | — |
| Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. | — |
| Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. | — |
| Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred. | Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition). |
| Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken | The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results. |
| Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). | Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B. |
| Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. | Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image. |
| Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image. |
| Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. | Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image. |
| Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur. | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image. |
| Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants | Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL. | — |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants | Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL. | — |
| Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image. |
| Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). | Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Risk Prostate Cancer (Cohort A) Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. | 268 |
| Recurrent or Metastatic Prostate Cancer (Cohort B) Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. | 117 |
| Total | 385 |
Baseline characteristics
| Characteristic | High Risk Prostate Cancer (Cohort A) | Recurrent or Metastatic Prostate Cancer (Cohort B) | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 68 years | 66 years |
| Race/Ethnicity, Customized Race Asian | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Black or African American | 23 Participants | 6 Participants | 29 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 233 Participants | 101 Participants | 334 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 268 Participants | 117 Participants | 385 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 268 | 0 / 117 |
| other Total, other adverse events | 26 / 268 | 1 / 117 |
| serious Total, serious adverse events | 1 / 268 | 6 / 117 |
Outcome results
Primary
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Central Reader 1 | 41.9 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Central Reader 2 | 30.6 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Central Reader 3 | 40.3 percentage of participants |
Primary
Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Central Reader 1 | 97.9 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Central Reader 2 | 98.9 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | Central Reader 3 | 96.3 percentage of participants |
Secondary
Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants
Time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Population: Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants | 0.82 h*μCi/ml | Standard Deviation 0.143 |
Secondary
Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)
Time frame: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Normal ECG Evaluation | 159 Participants |
| High Risk Prostate Cancer (Cohort A) | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Abnormal ECG Evaluation | 101 Participants |
| Cohort B - Follow-up Value: Low | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Abnormal ECG Evaluation | 109 Participants |
| Cohort B - Follow-up Value: Low | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Normal ECG Evaluation | 155 Participants |
| Cohort A - Follow-up Value: Normal | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Normal ECG Evaluation | 55 Participants |
| Cohort A - Follow-up Value: Normal | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Abnormal ECG Evaluation | 59 Participants |
| Cohort B - Follow-up Value Normal | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Normal ECG Evaluation | 51 Participants |
| Cohort B - Follow-up Value Normal | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Abnormal ECG Evaluation | 64 Participants |
Secondary
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging
The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.
Time frame: Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken
Population: The Evaluable Set consisted of high risk cancer participants (Cohort A) who received 18F-DCFPyL and had a prostatectomy or lymphadenectomy, and participants with recurrent or metastatic prostate cancer (Cohort B) who received 18F-DCFPyL and had a conventional image-guided biopsy, and had an 18F-DCFPyL PET/CT imaging result and a corresponding histology result.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 2 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 10 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 35 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 239 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 16 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 39 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 109 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 16 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 233 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 157 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 17 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 29 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 162 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 16 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 88 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 9 Participants |
| High Risk Prostate Cancer (Cohort A) | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 75 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 17 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 5 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 216 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 28 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 234 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 9 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 55 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 1 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 174 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 0 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 3 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 10 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 241 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 11 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 38 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 11 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 199 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 0 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 5 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 0 Participants |
| Cohort B - Follow-up Value: Low | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 3 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 4 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 3 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 0 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 209 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 226 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 196 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 5 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 247 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 3 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 0 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 10 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 0 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 1 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 0 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 4 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 19 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 3 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 38 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 249 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 4 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 0 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 33 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 0 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 1 Participants |
| Cohort A - Follow-up Value: Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 5 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 5 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 237 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 13 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 2 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 0 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 240 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 12 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 0 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 0 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 218 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 25 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 3 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 1 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 14 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 204 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 31 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 3 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 14 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 175 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 47 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 11 Participants |
| Cohort B - Follow-up Value Normal | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 5 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 8 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 26 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 0 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 72 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 7 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 13 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 0 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 12 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 2 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 9 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 8 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 8 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 2 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 11 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 50 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 18 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 22 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 37 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 14 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 1 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 20 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 3 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 0 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 37 Participants |
| Cohort A - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 79 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 71 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 7 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 1 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 8 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 9 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 29 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 2 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 64 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 15 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 20 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 6 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 22 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 1 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 37 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 2 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 3 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 3 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 10 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 15 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 56 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 10 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 21 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 38 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 11 Participants |
| Cohort B - Follow-up Value: High | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 4 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 73 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 69 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 10 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 3 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 1 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 5 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 23 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 11 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 4 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 46 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 1 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 17 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 24 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 13 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 4 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 16 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 9 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 0 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 22 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 28 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 2 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 1 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 14 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 32 Participants |
| Cohort A - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 37 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 1-2 | 14 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 5-6 | 0 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 0 | 38 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 5-6 | 8 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 5-6 | 2 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 1-2 | 22 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 1-2 | 20 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 0 | 63 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 3-4 | 0 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: >6 | 0 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 0 | 23 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 5-6 | 0 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: >6 | 27 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: >6 | 53 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 5-6 | 11 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: >6 | 5 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: >6 | 36 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 0 | 7 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Bone | Number of Lesions: 3-4 | 10 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: All | Number of Lesions: 3-4 | 8 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 1-2 | 10 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Prostate Gland | Number of Lesions: 1-2 | 30 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 3-4 | 4 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Lymph Nodes | Number of Lesions: 3-4 | 10 Participants |
| Cohort B - Follow-up Value: Missing | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | Tissue Site: Visceral/Soft Tissue | Number of Lesions: 0 | 64 Participants |
Comparison: Tissue Site: Bonep-value: 0.1097Fisher Exact
Comparison: Tissue Site: Bonep-value: 0.1087Fisher Exact
Comparison: Tissue Site: Bonep-value: 0.1949Fisher Exact
Comparison: Tissue Site: Bonep-value: 0.1315Fisher Exact
Comparison: Tissue Site: Bonep-value: 0.1977Fisher Exact
Comparison: Tissue Site: Bonep-value: 0.2149Fisher Exact
Comparison: Tissue Site: Visceral/Soft tissuep-value: 0.2582Fisher Exact
Comparison: Tissue Site: Visceral/Soft tissuep-value: 0.0009Fisher Exact
Comparison: Tissue Site: Visceral/Soft tissuep-value: 0.3588Fisher Exact
Comparison: Tissue Site: Visceral/Soft tissuep-value: 0.8791Fisher Exact
Comparison: Tissue Site: Visceral/Soft tissuep-value: 0.9457Fisher Exact
Comparison: Tissue Site: Visceral/Soft tissuep-value: 0.2705Fisher Exact
Comparison: Tissue Type: Lymph nodesp-value: <0.0001Chi-squared
Comparison: Tissue Type: Lymph nodesp-value: <0.0001Chi-squared
Comparison: Tissue Type: Lymph nodesp-value: <0.0001Chi-squared
Comparison: Tissue Type: Lymph nodesp-value: 0.5933Chi-squared
Comparison: Tissue Type: Lymph nodesp-value: 0.7094Chi-squared
Comparison: Tissue Type: Lymph nodesp-value: 0.5424Chi-squared
Comparison: Tissue Site: Prostate Glandp-value: <0.0001Chi-squared
Comparison: Tissue Site: Prostate Glandp-value: <0.0001Fisher Exact
Comparison: Tissue Site: Prostate Glandp-value: <0.0001Fisher Exact
Comparison: Tissue Site: Prostate Glandp-value: 0.0038Fisher Exact
Comparison: Tissue Site: Prostate Glandp-value: 0.0647Fisher Exact
Comparison: Tissue Site: Prostate Glandp-value: 0.0021Chi-squared
Comparison: Tissue Site: Allp-value: <0.0001Chi-squared
Comparison: Tissue Site: Allp-value: <0.0001Chi-squared
Comparison: Tissue Site: Allp-value: <0.0001Chi-squared
Comparison: Tissue Site: Allp-value: 0.0815Chi-squared
Comparison: Tissue Site: Allp-value: 0.7507Chi-squared
Comparison: Tissue Site: Allp-value: 0.562Chi-squared
Secondary
Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Heart Rate: Change from Baseline | -4.4 beats per minute | Standard Deviation 6.88 |
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Heart Rate: Baseline (Actual) | 70.7 beats per minute | Standard Deviation 12.03 |
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Heart Rate: Post-dosing (Actual) | 66.4 beats per minute | Standard Deviation 10.98 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Heart Rate: Baseline (Actual) | 71.3 beats per minute | Standard Deviation 12.94 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Heart Rate: Post-dosing (Actual) | 67.0 beats per minute | Standard Deviation 11.23 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Heart Rate: Change from Baseline | -4.6 beats per minute | Standard Deviation 6.53 |
Secondary
Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Respiration Rate: Baseline (Actual) | 16.7 breaths per minute | Standard Deviation 3.33 |
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Respiration Rate: Post-dosing (Actual) | 16.6 breaths per minute | Standard Deviation 3.32 |
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Respiration Rate: Change from Baseline | -0.1 breaths per minute | Standard Deviation 2.03 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Respiration Rate: Baseline (Actual) | 17.3 breaths per minute | Standard Deviation 2.16 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Respiration Rate: Post-dosing (Actual) | 17.3 breaths per minute | Standard Deviation 2.28 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Respiration Rate: Change from Baseline | 0.0 breaths per minute | Standard Deviation 2 |
Secondary
Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Temperature: Baseline (Actual) | 36.58 degrees Celsius | Standard Deviation 0.433 |
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Temperature: Post-dosing (Actual) | 36.50 degrees Celsius | Standard Deviation 0.479 |
| High Risk Prostate Cancer (Cohort A) | Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Temperature: Change from Baseline | -0.08 degrees Celsius | Standard Deviation 0.496 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Temperature: Baseline (Actual) | 36.56 degrees Celsius | Standard Deviation 0.338 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Temperature: Post-dosing (Actual) | 36.59 degrees Celsius | Standard Deviation 0.309 |
| Cohort B - Follow-up Value: Low | Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Temperature: Change from Baseline | 0.03 degrees Celsius | Standard Deviation 0.265 |
Secondary
Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Systolic Blood Pressure: Baseline (Actual) | 133.7 mm Hg | Standard Deviation 15.99 |
| High Risk Prostate Cancer (Cohort A) | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Systolic Blood Pressure: Post-dosing (Actual) | 133.7 mm Hg | Standard Deviation 16.57 |
| High Risk Prostate Cancer (Cohort A) | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Systolic Blood Pressure: Change from Baseline | 0.1 mm Hg | Standard Deviation 12.3 |
| High Risk Prostate Cancer (Cohort A) | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Diastolic Blood Pressure: Baseline (Actual) | 79.3 mm Hg | Standard Deviation 8.62 |
| High Risk Prostate Cancer (Cohort A) | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Diastolic Blood Pressure: Post-dosing (Actual) | 78.5 mm Hg | Standard Deviation 9.12 |
| High Risk Prostate Cancer (Cohort A) | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Diastolic Blood Pressure: Change from Baseline | -0.7 mm Hg | Standard Deviation 7.04 |
| Cohort B - Follow-up Value: Low | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Diastolic Blood Pressure: Post-dosing (Actual) | 76.4 mm Hg | Standard Deviation 9.02 |
| Cohort B - Follow-up Value: Low | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Systolic Blood Pressure: Baseline (Actual) | 133.6 mm Hg | Standard Deviation 19 |
| Cohort B - Follow-up Value: Low | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Diastolic Blood Pressure: Baseline (Actual) | 77.2 mm Hg | Standard Deviation 10.16 |
| Cohort B - Follow-up Value: Low | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Systolic Blood Pressure: Post-dosing (Actual) | 132.1 mm Hg | Standard Deviation 19.11 |
| Cohort B - Follow-up Value: Low | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Diastolic Blood Pressure: Change from Baseline | -0.7 mm Hg | Standard Deviation 8.18 |
| Cohort B - Follow-up Value: Low | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Systolic Blood Pressure: Change from Baseline | -1.3 mm Hg | Standard Deviation 11.57 |
Secondary
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 1 | 83.8 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 2 | 81.4 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 3 | 83.2 percentage of participants |
Secondary
Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 1 | 0 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 2 | 0 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 3 | 0 percentage of participants |
Secondary
Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants
Time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Population: Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants | 0.43 µCi/mL | Standard Deviation 0.088 |
Secondary
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.
Time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.
Population: The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Central Reader 1 | 81.2 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Central Reader 2 | 81.9 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Central Reader 3 | 87.8 percentage of participants |
Secondary
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 1 | 86.7 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 2 | 90.5 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 3 | 78.1 percentage of participants |
Secondary
Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Population: The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and had a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 1 | 100.0 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 2 | 100.0 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Central Reader 3 | 100.0 percentage of participants |
Secondary
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).
Time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.
Population: Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Central Reader 1 | 98.6 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Central Reader 2 | 95.8 percentage of participants |
| High Risk Prostate Cancer (Cohort A) | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Central Reader 3 | 92.9 percentage of participants |
Secondary
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)
Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
Time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 2 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 3 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 5 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 5 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 25 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 1 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 4 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 8 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 3 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 2 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 1 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 2 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 1 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 2 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 222 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 3 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 11 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 4 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 3 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 223 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 193 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 210 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 3 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 4 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 226 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 197 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 5 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 4 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 7 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 194 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 20 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 219 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 4 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 155 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 9 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 54 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 75 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 69 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 66 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 67 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 4 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 3 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 61 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 25 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 60 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 13 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 81 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 6 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 7 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 8 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 7 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 3 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 7 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 14 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 4 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 8 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 22 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 1 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 9 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 8 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 19 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 53 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 8 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 2 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 6 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 1 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 16 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 9 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 14 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 4 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 29 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 2 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 4 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 5 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 2 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 2 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 4 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 2 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 5 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 43 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 4 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 7 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 18 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 35 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 18 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 38 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 15 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 12 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 9 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 33 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: High | 2 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Normal | 32 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Normal | 16 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Normal | 41 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: Normal | 42 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Glucose | Cohort B - Baseline Value: High | 17 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Low | 4 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: Normal | 32 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: Normal | 35 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: High | 10 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alanine Aminotransferase | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Calcium | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Normal | 35 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Potassium | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Aspartate Aminotransferase | Cohort B - Baseline Value: Normal | 45 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Creatinine | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort B - Baseline Value: High | 4 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Urea Nitrogen | Cohort B - Baseline Value: Normal | 25 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Bilirubin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Alkaline Phosphatase | Cohort A - Baseline Value: Missing | 0 Participants |
Secondary
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
Time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 18 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 29 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 16 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 26 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 12 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 4 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 29 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 20 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 7 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 4 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| High Risk Prostate Cancer (Cohort A) | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 9 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 2 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 36 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 7 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 3 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 1 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 31 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 33 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 6 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Low | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 8 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 179 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 3 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 4 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 12 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 7 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 210 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 208 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 3 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 3 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 3 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 1 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 230 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 194 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 2 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 2 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 6 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 6 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 3 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 2 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 71 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 39 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 47 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 43 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 70 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value Normal | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 1 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 5 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 1 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 1 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 18 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 1 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 2 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 1 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: High | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 2 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 2 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 12 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 2 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 13 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 11 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 11 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 2 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 1 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 12 Participants |
| Cohort A - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 1 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Normal | 29 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Low | 10 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Low | 3 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Normal | 22 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Normal | 22 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Erythrocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: High | 1 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Low | 2 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Normal | 18 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort B - Baseline Value: Low | 13 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hemoglobin | Cohort A - Baseline Value: Low | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Low | 10 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: Normal | 30 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Leukocytes | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: High | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort B - Baseline Value: Missing | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Hematocrit | Cohort A - Baseline Value: Normal | 0 Participants |
| Cohort B - Follow-up Value: Missing | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Platelets | Cohort A - Baseline Value: High | 0 Participants |