Trial Outcomes & Findings for Epigenetic Reprogramming in Relapse/Refractory AML (NCT NCT03263936)
NCT ID: NCT03263936
Last Updated: 2025-10-16
Results Overview
The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
during course 1 DLT evaluation period, approx 9 weeks
Results posted on
2025-10-16
Participant Flow
Participant milestones
| Measure |
Dose Level #1: 7.5 mg/m2
Decitabine Dose Level #1: 7.5 mg/m2 given IV over 1 hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO on Days 1-5
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0) Days 5-12
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF) Days 6-10
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level #2: 10 mg/m2
Decitabine Dose Level #2: 10 mg/m2 given IV over 1 hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO on Days 1-5
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0) Days 5-12
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF) Days 6-10
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level #3: 15 mg/m2
Decitabine Dose Level #3: 15 mg/m2 given IV over 1 hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO on Days 1-5
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0) Days 5-12
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF) Days 6-10
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
22
|
12
|
|
Overall Study
COMPLETED
|
3
|
20
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Dose Level #1: 7.5 mg/m2
Decitabine Dose Level #1: 7.5 mg/m2 given IV over 1 hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO on Days 1-5
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0) Days 5-12
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF) Days 6-10
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level #2: 10 mg/m2
Decitabine Dose Level #2: 10 mg/m2 given IV over 1 hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO on Days 1-5
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0) Days 5-12
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF) Days 6-10
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level #3: 15 mg/m2
Decitabine Dose Level #3: 15 mg/m2 given IV over 1 hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO on Days 1-5
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0) Days 5-12
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF) Days 6-10
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Epigenetic Reprogramming in Relapse/Refractory AML
Baseline characteristics by cohort
| Measure |
Dose Level 1 (Decitabine = 7.5mg/m2)
n=3 Participants
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #1: 7.5 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level 2 (Decitabine 10mg/m2)
n=22 Participants
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #2: 10 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level 3 (Decitabine 15 mg/m2)
n=12 Participants
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #3: 15 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.18 Years
n=5 Participants
|
7.59 Years
n=7 Participants
|
11.46 Years
n=5 Participants
|
8.4 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
21 participants
n=7 Participants
|
11 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during course 1 DLT evaluation period, approx 9 weeksThe incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Decitabine = 7.5 mg/m2
|
Dose Level 2
n=22 Participants
Decitabine = 10 mg/m2
|
Dose Level 3
n=12 Participants
Decitabine = 15mg/m2
|
|---|---|---|---|
|
The Dose of Decitabine That Can be Safely Given With Vorinostat, Fludarabine, High Dose Cytarabine and G-CSF (FLAG)
Patient completed therapy without DLT
|
3 Participants
|
20 Participants
|
12 Participants
|
|
The Dose of Decitabine That Can be Safely Given With Vorinostat, Fludarabine, High Dose Cytarabine and G-CSF (FLAG)
Patient experienced DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Dose of Decitabine That Can be Safely Given With Vorinostat, Fludarabine, High Dose Cytarabine and G-CSF (FLAG)
Patients withdrew or not evaluable
|
0 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Dose Level 1 (Decitabine = 7.5mg/m2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 2 (Decitabine 10mg/m2)
Serious events: 18 serious events
Other events: 22 other events
Deaths: 22 deaths
Dose Level 3 (Decitabine 15 mg/m2)
Serious events: 12 serious events
Other events: 12 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Dose Level 1 (Decitabine = 7.5mg/m2)
n=3 participants at risk
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #1: 7.5 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level 2 (Decitabine 10mg/m2)
n=22 participants at risk
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #2: 10 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level 3 (Decitabine 15 mg/m2)
n=12 participants at risk
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #3: 15 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Edema Limbs
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Encephalitis Infection
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Disseminated Fungal Infection (Trichosporon Asahii)
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Fungemia Candida Parapsilosis Blood Line Infection
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Candida Parapsilosis
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Disseminated Fungal, Mucor
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia Disease Progression
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Paraplegia NOS
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Bilateral Erythematous Knee Lesions
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
Other adverse events
| Measure |
Dose Level 1 (Decitabine = 7.5mg/m2)
n=3 participants at risk
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #1: 7.5 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level 2 (Decitabine 10mg/m2)
n=22 participants at risk
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #2: 10 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
Dose Level 3 (Decitabine 15 mg/m2)
n=12 participants at risk
decitabine, vorinostat, fludarabine, high dose cytarabine, filgrastim (G-CSF)
Decitabine Dose Level #3: 15 mg/m2
given IV over \_\_ hour on days 1 through 5
Vorinostat: Age \<18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
Filgrastim (G-CSF): Given on days 5 until evidence of ANC recovery (\>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
Fludarabine: 30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
Cytarabine: 2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
45.5%
10/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
50.0%
6/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Non-specific ST and T Wave Abnormality
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
27.3%
6/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
33.3%
4/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Eye disorders
Dry Eye
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Eye disorders
Itching, Burning
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Eye disorders
Vision Loss
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Eye disorders
Flashing Lights
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
22.7%
5/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
36.4%
8/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Cardiac disorders
Constipation
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
31.8%
7/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
22.7%
5/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
90.9%
20/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
91.7%
11/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Blood and lymphatic system disorders
Positive Blood Culture (MRSE)
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Blood and lymphatic system disorders
PICC Line Bleeding
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Gingival Erythemia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Mucositis Oral
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
40.9%
9/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
58.3%
7/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
27.3%
6/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Chills
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Edema Face
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Facial Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Fever
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
45.5%
10/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
41.7%
5/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Pain
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Neck Edema
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Localized Edema - Scrotum
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Localized Edema
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Blood infection
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Coagulase Negative Staphylococcus
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Oral Mucosa
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
HHV6
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Escherichia Coli
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Alpha Streptococcus not Streptococcus Pneumoniae, Group A or B
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Human Rhinovirus
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Lung Infection
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
18.2%
4/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Nail Infection
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Infections and infestations
Papulopustular rash
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Injury, poisoning and procedural complications
Head Bump with Small Scab
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
40.9%
9/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
41.7%
5/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Alkaline Phosphatase Increased
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
45.5%
10/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
41.7%
5/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Blood Bilirubin Increased
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
40.9%
9/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
CD4 Lymphocytes decreased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Creatinine Increased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Electrocardiogram QT Corrected Interval Prolonged
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Fibrinogen Decreased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
INR Increased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Hyperphosphatemia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Lymphocyte Count Decreased
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
63.6%
14/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
66.7%
8/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Lymphocyte Count Increased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
3/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
86.4%
19/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
58.3%
7/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Platelet Count Decreased
|
100.0%
3/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
86.4%
19/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
91.7%
11/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Weight Gain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Weight Loss
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
22.7%
5/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
White Blood Cell Decreased
|
100.0%
3/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
81.8%
18/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
83.3%
10/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
Hemoglobin Increased
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Investigations
GGT Increased
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
31.8%
7/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
40.9%
9/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
50.0%
6/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
18.2%
4/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
18.2%
4/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
59.1%
13/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
33.3%
4/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
36.4%
8/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
3/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
68.2%
15/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
75.0%
9/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
22.7%
5/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
50.0%
11/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
58.3%
7/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Hypophosphatemia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
36.4%
8/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
41.7%
5/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Physical Deconditioning
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Trunk
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
22.7%
5/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
50.0%
6/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Pseudotumor Cerebri
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Reproductive system and breast disorders
Penile Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Reproductive system and breast disorders
Scrotal Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
31.8%
7/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
18.2%
4/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
16.7%
2/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
33.3%
4/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
RSV Virus
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Parainfluenza
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinovirus
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
13.6%
3/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Hemorrhage
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Mucositis
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
9.1%
2/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Pressure Injury of Buttock
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other Specify: Fungal Lesion
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
8.3%
1/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Erythematous Knee Lesion, Right Knee
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Macular Rash
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation at G Tube Site
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
31.8%
7/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
33.3%
4/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
27.3%
6/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
25.0%
3/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/3 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
4.5%
1/22 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
0.00%
0/12 • Through 30 days after the last day of protocol therapy (Cycle 1 only), approximately 9 weeks total duration.
|
Additional Information
Ellynore Florendo
Therapeutic Advanced in Childhood Leukemia and Lymphoma
Phone: 323-361-3022
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place