Trial Outcomes & Findings for Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) (NCT NCT02624388)
NCT ID: NCT02624388
Last Updated: 2024-05-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
Results posted on
2024-05-06
Participant Flow
Participant milestones
| Measure |
Arm A: Genistein Followed by Placebo
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
Baseline characteristics by cohort
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14 years
n=5 Participants
|
10 years
n=7 Participants
|
12 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
Placebo cycles
|
15.5 days
Standard Deviation 1.73
|
13.5 days
Standard Deviation 2.12
|
—
|
—
|
|
Time to Neutrophil Count Recovery Following Myelosuppressive Chemotherapy
Genistein cycles
|
13.75 days
Standard Deviation 1.26
|
12.67 days
Standard Deviation 2.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
ESR, Genistein cycles
|
14.67 mm/hr
Standard Deviation 4.93
|
3.25 mm/hr
Standard Deviation 1.5
|
—
|
—
|
|
Serum Marker Levels of Inflammation Erythrocyte Sedimentation Rate (ESR; mm/hr) During Cycles of Chemotherapy
ESR, Placebo cycles
|
20.00 mm/hr
Standard Deviation 5.29
|
2.50 mm/hr
Standard Deviation 0.58
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysThis includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Outcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
Genistein Cycles
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
|
Number of Days That Participants Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
Placebo Cycles
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysThis includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Outcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
Genistein Cycles
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
Placebo Cycles
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysThis includes hearing loss/tinnitus, motor neuropathy, oral mucositis
Outcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Severity of Adverse Events That Are Commonly Caused by Chemotherapy Treatment Based on CTCAE Severity Criteria
|
0 Events
Interval 0.0 to 0.0
|
0 Events
Interval 0.0 to 0.0
|
0 Events
Interval 0.0 to 0.0
|
0 Events
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
Genistein cycles
|
0.75 days
Standard Deviation 0.5
|
0.5 days
Standard Deviation 0.58
|
—
|
—
|
|
Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
Placebo cycles
|
0.5 days
Standard Deviation 0.58
|
0.25 days
Standard Deviation 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event
Placebo Cycles
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
|
Number of Days That Planned Cancer Treatment is Delayed Due to an Adverse Event
Genistein Cycles
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Percentage of Participants Requiring Reduced Treatment Doses Due to an Adverse Event
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Number of Days That Antimicrobial Treatment is Administered
Genistein cycles
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
—
|
—
|
|
Number of Days That Antimicrobial Treatment is Administered
Placebo cycles
|
0 days
Interval 0.0 to 0.0
|
5 days
Interval 0.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=4 cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=4 cycles
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
Genistein cycles
|
2 cycles
|
0 cycles
|
—
|
—
|
|
Number of Cycles Where Granulocyte-colony Stimulating Factor (G-CSF) is Administered
Placebo cycles
|
0 cycles
|
0 cycles
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest
Genistein cycles
|
0.75 transfusions
Standard Deviation 0.96
|
1.00 transfusions
Standard Deviation 1.15
|
—
|
—
|
|
Number of Times That a Blood Product is Administered for Anemia, Decreased Platelets, Abnormal Bleeding, or the Subject's Best Interest
Placebo cycles
|
1.25 transfusions
Standard Deviation 0.50
|
0.75 transfusions
Standard Deviation 0.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Once before treatment starts and then four more times while the study drug is being taken, an 8 - 16 week period if there are no chemotherapy delaysOutcome measures
| Measure |
Arm A: Genistein Followed by Placebo
n=2 Participants
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein
n=2 Participants
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy
CRP, Genistein cycles
|
0.37 mg/dL
Standard Deviation 0.29
|
0.13 mg/dL
Standard Deviation 0.05
|
—
|
—
|
|
Serum Marker Levels of Inflammation C-reactive Protein (CRP; mg/dL) During Cycles of Chemotherapy
CRP, Placebo cycles
|
0.33 mg/dL
Standard Deviation 0.26
|
0.15 mg/dL
Standard Deviation 0.10
|
—
|
—
|
Adverse Events
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
n=2 participants at risk
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
n=2 participants at risk
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
n=2 participants at risk
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
n=2 participants at risk
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
febrile neutropenia
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
Other adverse events
| Measure |
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
n=2 participants at risk
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
n=2 participants at risk
Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm A: Genistein Followed by Placebo - PLACEBO Cycles
n=2 participants at risk
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
Arm B: Placebo Followed by Genistein - PLACEBO Cycles
n=2 participants at risk
Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4
Genistein: Estrogen-like compound (isoflavone) derived from soybeans
Placebo: Pill that contains no medicine
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
50.0%
1/2 • Number of events 2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
100.0%
2/2 • Number of events 2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Gastrointestinal disorders
Anal mucositis
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Investigations
Neutrophil count decreased
|
100.0%
2/2 • Number of events 3 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 4 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Investigations
Platelet count decreased
|
100.0%
2/2 • Number of events 9 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 9 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Investigations
White blood cell count decreased
|
100.0%
2/2 • Number of events 2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 3 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Nervous system disorders
Peripheral sensory Neuropathy
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Cardiac disorders
sinus tachycardia
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Cardiac disorders
Prolonged QTC interval
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 4 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Immune system disorders
Bladder infection
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
General disorders
Pain
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
General disorders
Malaise
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Infections and infestations
Eye infection
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
50.0%
1/2 • Number of events 1 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
0.00%
0/2 • All AEs collected through 30 days after the last study supplement dose. In addition, investigators must report any deaths, SAEs, other AEs of concern that are believed to be related to the investigational intervention, cancer progression, cancer relapse, and secondary malignancies through six months after the end of the study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place