Trial Outcomes & Findings for Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer (NCT NCT00118040)
NCT ID: NCT00118040
Last Updated: 2021-06-10
Results Overview
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
up to 21 days
Results posted on
2021-06-10
Participant Flow
Participants were recruited during a 3 year period by staff at 7 participating institutions (both University hospitals and community clinics).
Participant milestones
| Measure |
Arm I (300mg Genistein)
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
6
|
Reasons for withdrawal
| Measure |
Arm I (300mg Genistein)
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Medical Contraindication
|
0
|
0
|
1
|
|
Overall Study
Non-Compliant Participant
|
1
|
1
|
2
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer
Baseline characteristics by cohort
| Measure |
Arm I (300mg Genistein)
n=20 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=20 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=20 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
38 Participants
n=31 Participants
|
|
Age, Continuous
|
68.60 years
STANDARD_DEVIATION 9.16 • n=39 Participants
|
68.65 years
STANDARD_DEVIATION 9.16 • n=41 Participants
|
71.95 years
STANDARD_DEVIATION 12.67 • n=35 Participants
|
69.73 years
STANDARD_DEVIATION 10.40 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
52 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
60 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
60 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=39 Participants
|
20 participants
n=41 Participants
|
20 participants
n=35 Participants
|
60 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to 21 daysPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=19 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=18 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=15 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=37 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment
Strong
|
52.63 percentage of pEGFR strength signal
|
83.33 percentage of pEGFR strength signal
|
93.33 percentage of pEGFR strength signal
|
67.57 percentage of pEGFR strength signal
|
|
Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment
Moderate
|
21.35 percentage of pEGFR strength signal
|
16.67 percentage of pEGFR strength signal
|
0.00 percentage of pEGFR strength signal
|
18.92 percentage of pEGFR strength signal
|
|
Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment
Weak
|
26.32 percentage of pEGFR strength signal
|
0.00 percentage of pEGFR strength signal
|
6.67 percentage of pEGFR strength signal
|
13.51 percentage of pEGFR strength signal
|
|
Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment
Negative
|
0.00 percentage of pEGFR strength signal
|
0.00 percentage of pEGFR strength signal
|
0.00 percentage of pEGFR strength signal
|
0.00 percentage of pEGFR strength signal
|
PRIMARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.
Detecting the signal of the biomarker, pEGFR, in the benign tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=22 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=9 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=14 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=8 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
pEGFR in Benign Tissue
Strong
|
4.55 percentage of pEGFR strength signal
|
0.00 percentage of pEGFR strength signal
|
7.14 percentage of pEGFR strength signal
|
0.00 percentage of pEGFR strength signal
|
|
pEGFR in Benign Tissue
Moderate
|
27.27 percentage of pEGFR strength signal
|
33.33 percentage of pEGFR strength signal
|
28.57 percentage of pEGFR strength signal
|
25.00 percentage of pEGFR strength signal
|
|
pEGFR in Benign Tissue
Weak
|
54.55 percentage of pEGFR strength signal
|
44.44 percentage of pEGFR strength signal
|
57.14 percentage of pEGFR strength signal
|
50.00 percentage of pEGFR strength signal
|
|
pEGFR in Benign Tissue
Negative
|
13.64 percentage of pEGFR strength signal
|
22.22 percentage of pEGFR strength signal
|
7.14 percentage of pEGFR strength signal
|
25.00 percentage of pEGFR strength signal
|
SECONDARY outcome
Timeframe: up to 21 daysPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 17 for this outcome.
Detecting the mean amount of the biomarker BLCA-4 in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=39 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=17 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=20 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=19 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
BLCA-4 in Urine by Visit
Baseline
|
0.54 pg/ml
Standard Deviation 0.35
|
0.46 pg/ml
Standard Deviation 0.24
|
0.52 pg/ml
Standard Deviation 0.37
|
0.55 pg/ml
Standard Deviation 0.34
|
|
BLCA-4 in Urine by Visit
Day 8
|
0.52 pg/ml
Standard Deviation 0.42
|
0.53 pg/ml
Standard Deviation 0.20
|
0.54 pg/ml
Standard Deviation 0.42
|
0.50 pg/ml
Standard Deviation 0.43
|
|
BLCA-4 in Urine by Visit
Pre-Surgery
|
0.52 pg/ml
Standard Deviation 0.36
|
0.49 pg/ml
Standard Deviation 0.34
|
0.59 pg/ml
Standard Deviation 0.39
|
0.44 pg/ml
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: up to 21 daysPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 16 for this outcome.
Detecting the mean amount of the biomarker Survivin in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=16 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=18 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=19 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
Survivin in Urine by Visit (pg/ml)
Baseline
|
58.5 pg/ml
Standard Deviation 141.3
|
16.0 pg/ml
Standard Deviation 37.4
|
71.0 pg/ml
Standard Deviation 171.7
|
46.6 pg/ml
Standard Deviation 108.6
|
|
Survivin in Urine by Visit (pg/ml)
Day 8
|
41.0 pg/ml
Standard Deviation 123.8
|
17.8 pg/ml
Standard Deviation 32.6
|
60.3 pg/ml
Standard Deviation 175.7
|
23.7 pg/ml
Standard Deviation 41.1
|
|
Survivin in Urine by Visit (pg/ml)
Pre-Surgery
|
55.4 pg/ml
Standard Deviation 166.7
|
28.6 pg/ml
Standard Deviation 43.3
|
84.4 pg/ml
Standard Deviation 237.3
|
29.5 pg/ml
Standard Deviation 49.6
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, Survivin, in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
Survivin in Tumor Tissue
Strong
|
24.32 percentage of Survivin strength signal
|
0.00 percentage of Survivin strength signal
|
15.79 percentage of Survivin strength signal
|
33.33 percentage of Survivin strength signal
|
|
Survivin in Tumor Tissue
Moderate
|
13.51 percentage of Survivin strength signal
|
33.33 percentage of Survivin strength signal
|
15.79 percentage of Survivin strength signal
|
11.11 percentage of Survivin strength signal
|
|
Survivin in Tumor Tissue
Weak
|
35.14 percentage of Survivin strength signal
|
33.33 percentage of Survivin strength signal
|
26.32 percentage of Survivin strength signal
|
44.44 percentage of Survivin strength signal
|
|
Survivin in Tumor Tissue
Negative
|
27.03 percentage of Survivin strength signal
|
33.33 percentage of Survivin strength signal
|
42.11 percentage of Survivin strength signal
|
11.11 percentage of Survivin strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of EGFR mutations in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
EGFR Mutations in Tumor Tissue
Strong
|
48.65 percentage of EGFR strength signal
|
46.67 percentage of EGFR strength signal
|
42.11 percentage of EGFR strength signal
|
55.56 percentage of EGFR strength signal
|
|
EGFR Mutations in Tumor Tissue
Moderate
|
16.22 percentage of EGFR strength signal
|
0.00 percentage of EGFR strength signal
|
10.53 percentage of EGFR strength signal
|
22.22 percentage of EGFR strength signal
|
|
EGFR Mutations in Tumor Tissue
Weak
|
16.22 percentage of EGFR strength signal
|
6.67 percentage of EGFR strength signal
|
21.05 percentage of EGFR strength signal
|
11.11 percentage of EGFR strength signal
|
|
EGFR Mutations in Tumor Tissue
Negative
|
18.92 percentage of EGFR strength signal
|
46.67 percentage of EGFR strength signal
|
26.32 percentage of EGFR strength signal
|
11.11 percentage of EGFR strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.
Detecting the signal of the biomarker, EGFR, in the benign tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=22 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=9 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=14 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=8 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
EGFR in Benign Tissue
Negative
|
36.36 percentage of EGFR strength signal
|
66.67 percentage of EGFR strength signal
|
35.71 percentage of EGFR strength signal
|
37.50 percentage of EGFR strength signal
|
|
EGFR in Benign Tissue
Strong
|
40.91 percentage of EGFR strength signal
|
11.11 percentage of EGFR strength signal
|
42.86 percentage of EGFR strength signal
|
37.50 percentage of EGFR strength signal
|
|
EGFR in Benign Tissue
Moderate
|
13.64 percentage of EGFR strength signal
|
22.22 percentage of EGFR strength signal
|
7.14 percentage of EGFR strength signal
|
25.00 percentage of EGFR strength signal
|
|
EGFR in Benign Tissue
Weak
|
9.09 percentage of EGFR strength signal
|
0.00 percentage of EGFR strength signal
|
14.29 percentage of EGFR strength signal
|
0.00 percentage of EGFR strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, Ki-67, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
Ki-67 in Tumor Tissue
Strong
|
40.54 percentage of Ki-67 strength signal
|
26.67 percentage of Ki-67 strength signal
|
47.37 percentage of Ki-67 strength signal
|
33.33 percentage of Ki-67 strength signal
|
|
Ki-67 in Tumor Tissue
Moderate
|
18.92 percentage of Ki-67 strength signal
|
20.00 percentage of Ki-67 strength signal
|
15.79 percentage of Ki-67 strength signal
|
22.22 percentage of Ki-67 strength signal
|
|
Ki-67 in Tumor Tissue
Weak
|
35.14 percentage of Ki-67 strength signal
|
46.67 percentage of Ki-67 strength signal
|
31.58 percentage of Ki-67 strength signal
|
38.89 percentage of Ki-67 strength signal
|
|
Ki-67 in Tumor Tissue
Negative
|
5.41 percentage of Ki-67 strength signal
|
6.67 percentage of Ki-67 strength signal
|
5.26 percentage of Ki-67 strength signal
|
5.56 percentage of Ki-67 strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, Activated Caspase 3, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
Activated Caspase 3 in Tumor Tissue
Strong
|
10.81 percentage of Caspase 3 strength signal
|
0.00 percentage of Caspase 3 strength signal
|
10.53 percentage of Caspase 3 strength signal
|
11.11 percentage of Caspase 3 strength signal
|
|
Activated Caspase 3 in Tumor Tissue
Moderate
|
2.70 percentage of Caspase 3 strength signal
|
6.67 percentage of Caspase 3 strength signal
|
0.00 percentage of Caspase 3 strength signal
|
5.56 percentage of Caspase 3 strength signal
|
|
Activated Caspase 3 in Tumor Tissue
Weak
|
27.03 percentage of Caspase 3 strength signal
|
26.67 percentage of Caspase 3 strength signal
|
26.32 percentage of Caspase 3 strength signal
|
27.78 percentage of Caspase 3 strength signal
|
|
Activated Caspase 3 in Tumor Tissue
Negative
|
59.46 percentage of Caspase 3 strength signal
|
66.67 percentage of Caspase 3 strength signal
|
63.16 percentage of Caspase 3 strength signal
|
55.56 percentage of Caspase 3 strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, COX2, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
COX2 in Tumor Tissue
Strong
|
13.51 percentage of COX2 strength signal
|
0.00 percentage of COX2 strength signal
|
15.79 percentage of COX2 strength signal
|
11.11 percentage of COX2 strength signal
|
|
COX2 in Tumor Tissue
Moderate
|
32.43 percentage of COX2 strength signal
|
26.67 percentage of COX2 strength signal
|
36.84 percentage of COX2 strength signal
|
27.78 percentage of COX2 strength signal
|
|
COX2 in Tumor Tissue
Weak
|
16.22 percentage of COX2 strength signal
|
33.33 percentage of COX2 strength signal
|
5.26 percentage of COX2 strength signal
|
27.78 percentage of COX2 strength signal
|
|
COX2 in Tumor Tissue
Negative
|
37.84 percentage of COX2 strength signal
|
40.00 percentage of COX2 strength signal
|
42.11 percentage of COX2 strength signal
|
33.33 percentage of COX2 strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, AKT, in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
AKT in Tumor Tissue
Strong
|
64.86 percentage of AKT strength signal
|
60.00 percentage of AKT strength signal
|
78.95 percentage of AKT strength signal
|
50.00 percentage of AKT strength signal
|
|
AKT in Tumor Tissue
Moderate
|
10.81 percentage of AKT strength signal
|
13.33 percentage of AKT strength signal
|
5.26 percentage of AKT strength signal
|
16.67 percentage of AKT strength signal
|
|
AKT in Tumor Tissue
Weak
|
18.92 percentage of AKT strength signal
|
20.00 percentage of AKT strength signal
|
10.53 percentage of AKT strength signal
|
27.78 percentage of AKT strength signal
|
|
AKT in Tumor Tissue
Negative
|
5.41 percentage of AKT strength signal
|
6.67 percentage of AKT strength signal
|
5.26 percentage of AKT strength signal
|
5.56 percentage of AKT strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, pAKT, in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
pAKT in Tumor Tissue
Strong
|
43.24 percentage of pAKT strength signal
|
33.33 percentage of pAKT strength signal
|
47.37 percentage of pAKT strength signal
|
38.89 percentage of pAKT strength signal
|
|
pAKT in Tumor Tissue
Moderate
|
8.11 percentage of pAKT strength signal
|
0.00 percentage of pAKT strength signal
|
5.26 percentage of pAKT strength signal
|
11.11 percentage of pAKT strength signal
|
|
pAKT in Tumor Tissue
Weak
|
2.70 percentage of pAKT strength signal
|
6.67 percentage of pAKT strength signal
|
0.00 percentage of pAKT strength signal
|
5.56 percentage of pAKT strength signal
|
|
pAKT in Tumor Tissue
Negative
|
45.95 percentage of pAKT strength signal
|
60.00 percentage of pAKT strength signal
|
47.37 percentage of pAKT strength signal
|
44.44 percentage of pAKT strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, MAP Kinase, in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
MAP Kinase in Tumor Tissue
Strong
|
75.68 percentage of MAP Kinase strength signal
|
86.67 percentage of MAP Kinase strength signal
|
84.21 percentage of MAP Kinase strength signal
|
66.67 percentage of MAP Kinase strength signal
|
|
MAP Kinase in Tumor Tissue
Moderate
|
16.22 percentage of MAP Kinase strength signal
|
6.67 percentage of MAP Kinase strength signal
|
10.53 percentage of MAP Kinase strength signal
|
22.22 percentage of MAP Kinase strength signal
|
|
MAP Kinase in Tumor Tissue
Weak
|
2.70 percentage of MAP Kinase strength signal
|
0.00 percentage of MAP Kinase strength signal
|
0.00 percentage of MAP Kinase strength signal
|
5.56 percentage of MAP Kinase strength signal
|
|
MAP Kinase in Tumor Tissue
Negative
|
5.41 percentage of MAP Kinase strength signal
|
6.67 percentage of MAP Kinase strength signal
|
5.26 percentage of MAP Kinase strength signal
|
5.56 percentage of MAP Kinase strength signal
|
SECONDARY outcome
Timeframe: up to 21 days on Study DrugPopulation: For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.
Detecting the signal of the biomarker, pMAP Kinase, in the tumor tissue after being on study drug for between 14-21 days. Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.
Outcome measures
| Measure |
Arm I (300mg Genistein)
n=37 Participants
Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm II (600mg Genistein)
n=15 Participants
Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm III (Placebo)
n=19 Participants
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
|
Arm IV (300mg Genistein + 600mg Genistein)
n=18 Participants
This is a combination analysis those on 300mg of genistein and 600mg genistein
|
|---|---|---|---|---|
|
pMAP Kinase in Tumor Tissue
Strong
|
48.65 percentage of pMAP Kinase strength signa
|
66.67 percentage of pMAP Kinase strength signa
|
36.84 percentage of pMAP Kinase strength signa
|
61.11 percentage of pMAP Kinase strength signa
|
|
pMAP Kinase in Tumor Tissue
Moderate
|
37.84 percentage of pMAP Kinase strength signa
|
20.00 percentage of pMAP Kinase strength signa
|
42.11 percentage of pMAP Kinase strength signa
|
33.33 percentage of pMAP Kinase strength signa
|
|
pMAP Kinase in Tumor Tissue
Weak
|
13.51 percentage of pMAP Kinase strength signa
|
6.67 percentage of pMAP Kinase strength signa
|
21.05 percentage of pMAP Kinase strength signa
|
5.56 percentage of pMAP Kinase strength signa
|
|
pMAP Kinase in Tumor Tissue
Negative
|
0.00 percentage of pMAP Kinase strength signa
|
6.67 percentage of pMAP Kinase strength signa
|
0.00 percentage of pMAP Kinase strength signa
|
0.00 percentage of pMAP Kinase strength signa
|
Adverse Events
Arm I (Lower Dose Genistein)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Arm II (Higher Dose Genistein)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm III (Placebo)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Lower Dose Genistein)
n=20 participants at risk
Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
genistein: Given orally
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies
|
Arm II (Higher Dose Genistein)
n=20 participants at risk
Patients receive oral genistein as in arm I but at a higher dose. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
genistein: Given orally
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies
|
Arm III (Placebo)
n=20 participants at risk
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
laboratory biomarker analysis: Correlative studies
placebo: Given orally
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular arrhythmia- Supraventricular tachycardia
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
Other adverse events
| Measure |
Arm I (Lower Dose Genistein)
n=20 participants at risk
Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
genistein: Given orally
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies
|
Arm II (Higher Dose Genistein)
n=20 participants at risk
Patients receive oral genistein as in arm I but at a higher dose. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
genistein: Given orally
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies
|
Arm III (Placebo)
n=20 participants at risk
Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
laboratory biomarker analysis: Correlative studies
placebo: Given orally
therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
pharmacological study: Correlative studies
|
|---|---|---|---|
|
Social circumstances
Fatigue
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Social circumstances
Sweating
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Skin and subcutaneous tissue disorders
Itiching
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Endocrine disorders
Diabetes
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
4/20 • Number of events 4 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 3 • up to 30 days from randomization
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Infections and infestations
Infection of brochus
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Infections and infestations
Infection of upper airway
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Infections and infestations
Infection of urinary tract
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
amylase
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
15.0%
3/20 • Number of events 4 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Bicarbonate, serum low
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
15.0%
3/20 • Number of events 3 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Elevated Bilirubin
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Creatinine
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
decreased bilirubin
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
decreased bun
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Elevated bun
|
20.0%
4/20 • Number of events 4 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Elevated Chloride
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
High chloride
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
hypercalcemia
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Gastrointestinal disorders
Hypocalcemia
|
0.00%
0/20 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
15.0%
3/20 • Number of events 3 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
hypoatremia
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
lipase
|
30.0%
6/20 • Number of events 6 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
low chloride
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
low creatinine
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
low protein in blood work
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Metabolism and nutrition disorders
Low total bilirubin
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Musculoskeletal and connective tissue disorders
Fullness in left jaw area
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Musculoskeletal and connective tissue disorders
muscle weakness extremity-upper
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
General disorders
Back Pain
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
General disorders
headache
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
General disorders
pain: Breast
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
General disorders
Pain: Esophagus
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
General disorders
Pain: Muscle
|
5.0%
1/20 • Number of events 2 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Respiratory, thoracic and mediastinal disorders
excess phlegm
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Renal and urinary disorders
urinary frequency
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Immune system disorders
lupus
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Immune system disorders
rhinitis
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
decreased red blood cells
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
elevated hematocrit
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
elevated platelets
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
elevated white blood cells
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
high platelets
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
hemoglobin
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
leukocytes
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
low hematocrit
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
10.0%
2/20 • Number of events 2 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
|
Blood and lymphatic system disorders
platelets
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
|
Cardiac disorders
hypertension
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
0.00%
0/20 • up to 30 days from randomization
|
5.0%
1/20 • Number of events 1 • up to 30 days from randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60