Trial Outcomes & Findings for CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT01881867)
NCT ID: NCT01881867
Last Updated: 2019-07-09
Results Overview
The Mann-Whitney-Wilcoxon (MWW) test will be used as part of the statistical analysis to determine quantification of T-cell responses to prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (PAP-GM-CSF), as assessed by quantification of interferon gamma levels measured using enzyme-linked immunospot (ELISPOT). The power is roughly equivalent to that based on the t-test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Day 70 (week 11)
Results posted on
2019-07-09
Participant Flow
Participant milestones
| Measure |
Cohort I (no Therapy)
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Cohort I (no Therapy)
n=26 Participants
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=28 Participants
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 70 (week 11)The Mann-Whitney-Wilcoxon (MWW) test will be used as part of the statistical analysis to determine quantification of T-cell responses to prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (PAP-GM-CSF), as assessed by quantification of interferon gamma levels measured using enzyme-linked immunospot (ELISPOT). The power is roughly equivalent to that based on the t-test.
Outcome measures
| Measure |
Cohort I (no Therapy)
n=15 Participants
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=25 Participants
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Quantification of T-cell Responses to Prostatic Acid Phosphatase Granulocyte-macrophage Colony-stimulating Factor (PAP-GM-CSF), Assessed by Quantification of Interferon Gamma Levels Measured Using Enzyme-linked Immunospot (ELISPOT)
|
212.2 T cell spots per 300,000 PBMC
Standard Deviation 111.97
|
199.68 T cell spots per 300,000 PBMC
Standard Deviation 182.4
|
SECONDARY outcome
Timeframe: Baseline to up to week 53Population: No subjects were tested for bystander antigen specific immune responses because there was no indication that there was an enhanced response in the primary objective.
Bystander antigen specific immune responses will be assessed to other ongoing and nascent antitumor responses (e.g., preferentially expressed antigen in melanoma, cancer/testis antigen 1B and/or tumor protein p53), additional tumor antigens specific to prostate cancer (e.g., prostate specific antigen \[PSA\] and/or prostate-specific membrane antigen), and memory viral responses (influenza A and cytomegalovirus, Epstein-Barr virus and influenza virus-derived peptides) using the interferon gamma ELISPOT assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to week 53Population: Cohort 1: 16 subjects analyzed at Week 01 and 8 subjects analyzed at Week 53. Cohort 2: 22 subjects analyzed at Week 01 and 5 subjects analyzed at Week 53.
Enumerated by the approved Veridex assay.
Outcome measures
| Measure |
Cohort I (no Therapy)
n=16 Participants
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=22 Participants
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Change in Circulating Tumor Cells
Week 01
|
2.56 Circulating Tumor Cells
Standard Deviation 7.88
|
1.45 Circulating Tumor Cells
Standard Deviation 2.97
|
|
Change in Circulating Tumor Cells
Week 53
|
2.63 Circulating Tumor Cells
Standard Deviation 5.97
|
0 Circulating Tumor Cells
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 11Population: Subjects for whom whole blood was collected at protocol specified timepoints
The absolute fold change from baseline of CD3+ cells
Outcome measures
| Measure |
Cohort I (no Therapy)
n=14 Participants
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=22 Participants
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Change in Number of Peripheral Blood Mononuclear Cell (PBMC) Subsets and T Lymphocyte Subsets
Week 06
|
1.05 fold change
Standard Deviation 0.29
|
2.33 fold change
Standard Deviation 1.02
|
|
Change in Number of Peripheral Blood Mononuclear Cell (PBMC) Subsets and T Lymphocyte Subsets
Week 11
|
1.21 fold change
Standard Deviation 0.34
|
1.77 fold change
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline to up to week 53Population: Study participants who provided blood for PSA testing and analysis
The change in prostate specific antigen (PSA) kinetics will be evaluated according to the recommendations from PSA Working Group (PSAWG). Analysis of PSA doubling time
Outcome measures
| Measure |
Cohort I (no Therapy)
n=24 Participants
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=28 Participants
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Change in Prostate Specific Antigen (PSA) Kinetics.
|
46.82 Weeks
Interval 17.49 to 76.15
|
8.15 Weeks
Interval -18.79 to 35.09
|
SECONDARY outcome
Timeframe: Baseline to up to week 6Population: Participants who provided blood samples to test for antibody levels to PAP
Will be measured by change in immunoglobulin G (IgG) and immunoglobulin M (IgM) levels quantified by standard enzyme-linked immunosorbent assay (ELISA). Fold change from baseline in week 6 titer
Outcome measures
| Measure |
Cohort I (no Therapy)
n=24 Participants
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=28 Participants
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Change in Vaccine-induced Antigen-specific Antibody Immune Response to Prostatic Acid Phosphatase (PAP)
IgG-IgM levels
|
8 fold change
Interval 0.5 to 256.0
|
8 fold change
Interval 1.0 to 64.0
|
|
Change in Vaccine-induced Antigen-specific Antibody Immune Response to Prostatic Acid Phosphatase (PAP)
IgG levels
|
4 fold change
Interval 1.0 to 32.0
|
2 fold change
Interval 1.0 to 128.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of participants that have survived
Outcome measures
| Measure |
Cohort I (no Therapy)
n=26 Participants
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=28 Participants
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Survival
|
22 Participants
|
25 Participants
|
Adverse Events
Cohort I (no Therapy)
Serious events: 2 serious events
Other events: 26 other events
Deaths: 4 deaths
Cohort II (Glycosylated Recombinant Human Interleukin-7)
Serious events: 8 serious events
Other events: 28 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cohort I (no Therapy)
n=26 participants at risk
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=28 participants at risk
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Investigations
Acute Kidney Injury
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Investigations
Acute kidney injury
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Investigations
Hypernatremia
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Investigations
Hypokalemia
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
Other adverse events
| Measure |
Cohort I (no Therapy)
n=26 participants at risk
Patients receive no treatment (observation) after completion of standard sipuleucel-T therapy through week 53.
|
Cohort II (Glycosylated Recombinant Human Interleukin-7)
n=28 participants at risk
Patients receive glycosylated recombinant human interleukin-7 SC every week for 4 weeks (on days 0, 7, 14, and 21) beginning 3-7 days after completion of standard sipuleucel-T therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed post-active 4 week treatment for duration of study, 53 weeks.
Glycosylated Recombinant Human Interleukin-7: Given SC
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 3 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Gastrointestinal disorders
dysphagia
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Left forearm hematoma
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Blood and lymphatic system disorders
Fatigue
|
19.2%
5/26 • Number of events 5 • 53 weeks
|
25.0%
7/28 • Number of events 8 • 53 weeks
|
|
Nervous system disorders
neuropathy
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Number of events 2 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
General disorders
General weakness
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Worsening of osteonecrosis of the jaw
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory symptoms
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Site injection reaction
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Generalized pruritis
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
maculopapular rash
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Vascular disorders
hypertension
|
7.7%
2/26 • Number of events 2 • 53 weeks
|
14.3%
4/28 • Number of events 4 • 53 weeks
|
|
Infections and infestations
Cellulitis
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
lower extremity pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Reproductive system and breast disorders
scrotal edema
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Investigations
hyponatremia
|
15.4%
4/26 • Number of events 4 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Vascular disorders
Bilateral pedal edema
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Endocrine disorders
hyperglycemia
|
7.7%
2/26 • Number of events 2 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
anemia
|
19.2%
5/26 • Number of events 5 • 53 weeks
|
10.7%
3/28 • Number of events 3 • 53 weeks
|
|
Blood and lymphatic system disorders
Decreased absolute neutrophil count
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Cardiac disorders
Bradycardia
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Gastrointestinal disorders
Decreased appetite
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Vascular disorders
hypotension
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
right groin pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Gastrointestinal disorders
Gut disturbance
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Hand spasm
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
3/26 • Number of events 3 • 53 weeks
|
14.3%
4/28 • Number of events 4 • 53 weeks
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
15.4%
4/26 • Number of events 4 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Reproductive system and breast disorders
Penile pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Gastrointestinal disorders
Epigastric pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Left ankle pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
0.00%
0/28 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Left hip pain/leg pain
|
7.7%
2/26 • Number of events 2 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Psychiatric disorders
Depression
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Nervous system disorders
Pain
|
3.8%
1/26 • Number of events 1 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
0.00%
0/26 • 53 weeks
|
28.6%
8/28 • Number of events 41 • 53 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 3 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
0.00%
0/26 • 53 weeks
|
14.3%
4/28 • Number of events 15 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 2 • 53 weeks
|
|
Infections and infestations
MRSA UTI
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
Decreased platelets
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 2 • 53 weeks
|
|
Investigations
Elevated ALT
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
achy joints
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Investigations
Elevated AST
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 3 • 53 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 53 weeks
|
10.7%
3/28 • Number of events 3 • 53 weeks
|
|
Vascular disorders
Lower extremity edema
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 4 • 53 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Injury, poisoning and procedural complications
Great toe injury with bleeding beneath nail
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
Decreased lymphocytes
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 3 • 53 weeks
|
|
Immune system disorders
Fever
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Immune system disorders
Flu-like symptoms
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Endocrine disorders
Gynecomastia
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Nervous system disorders
Headaches
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Endocrine disorders
Hot flashes
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
Hypophosphotemia
|
0.00%
0/26 • 53 weeks
|
7.1%
2/28 • Number of events 2 • 53 weeks
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
Elevated creatinine
|
0.00%
0/26 • 53 weeks
|
10.7%
3/28 • Number of events 3 • 53 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Immune system disorders
chills
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Right-side mid-back pain with degenerative changes
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Endocrine disorders
Neck pain with swelling due to enlarged cervical lymph nodes
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Infections and infestations
Head cold
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Nervous system disorders
Difficulty sleeping due to discomfort from great toe injury
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain with degenerative changes
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Nervous system disorders
Hyperesthesia
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Nervous system disorders
Right sciatic discomfort
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain right scapula
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
General disorders
Presyncopal episode
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
itchiness
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritic rash over right shin
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritic rash over buttocks
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Renal and urinary disorders
polyuria
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema left arm
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
|
Nervous system disorders
Fainting episode
|
0.00%
0/26 • 53 weeks
|
3.6%
1/28 • Number of events 1 • 53 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60