Trial Outcomes & Findings for Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer (NCT NCT02595879)
NCT ID: NCT02595879
Last Updated: 2025-11-13
Results Overview
Area Under the Concentration-Time Curve (AUC 0-last)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Up to 24 hours after dosing
Results posted on
2025-11-13
Participant Flow
Participant milestones
| Measure |
100 mg PO Triapine + Chemoradiation
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
Biospecimen Collection: Undergo collection of blood samples
Brachytherapy: Undergo LDR brachytherapy
Cisplatin: Given IV
Computed Tomography: Undergo FDG-PET/CT
External Beam Radiation Therapy: Undergo pelvic EBRT
Fludeoxyglucose F-18: Undergo FDG-PET/CT
High-Dose Rate Brachytherapy: Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Magnetic Resonance Imaging: Undergo MRI
Pharmacological Study: Correlative studies
Positron Emission Tomography: Undergo FDG-PET/CT
Triapine: Given IV and PO
|
150 mg PO Triapine + Chemoradiation
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
Biospecimen Collection: Undergo collection of blood samples
Brachytherapy: Undergo LDR brachytherapy
Cisplatin: Given IV
Computed Tomography: Undergo FDG-PET/CT
External Beam Radiation Therapy: Undergo pelvic EBRT
Fludeoxyglucose F-18: Undergo FDG-PET/CT
High-Dose Rate Brachytherapy: Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Magnetic Resonance Imaging: Undergo MRI
Pharmacological Study: Correlative studies
Positron Emission Tomography: Undergo FDG-PET/CT
Triapine: Given IV and PO
|
|---|---|---|
|
Cohort 1 / Dose Level 1
STARTED
|
3
|
0
|
|
Cohort 1 / Dose Level 1
COMPLETED
|
3
|
0
|
|
Cohort 1 / Dose Level 1
NOT COMPLETED
|
0
|
0
|
|
Cohort 2 / Dose Level 2
STARTED
|
0
|
4
|
|
Cohort 2 / Dose Level 2
COMPLETED
|
0
|
4
|
|
Cohort 2 / Dose Level 2
NOT COMPLETED
|
0
|
0
|
|
Cohort 3 / Dose Level 1
STARTED
|
3
|
0
|
|
Cohort 3 / Dose Level 1
COMPLETED
|
3
|
0
|
|
Cohort 3 / Dose Level 1
NOT COMPLETED
|
0
|
0
|
|
Expansion Cohort
STARTED
|
11
|
0
|
|
Expansion Cohort
COMPLETED
|
10
|
0
|
|
Expansion Cohort
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
100 mg PO Triapine + Chemoradiation
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
Biospecimen Collection: Undergo collection of blood samples
Brachytherapy: Undergo LDR brachytherapy
Cisplatin: Given IV
Computed Tomography: Undergo FDG-PET/CT
External Beam Radiation Therapy: Undergo pelvic EBRT
Fludeoxyglucose F-18: Undergo FDG-PET/CT
High-Dose Rate Brachytherapy: Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Magnetic Resonance Imaging: Undergo MRI
Pharmacological Study: Correlative studies
Positron Emission Tomography: Undergo FDG-PET/CT
Triapine: Given IV and PO
|
150 mg PO Triapine + Chemoradiation
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
Biospecimen Collection: Undergo collection of blood samples
Brachytherapy: Undergo LDR brachytherapy
Cisplatin: Given IV
Computed Tomography: Undergo FDG-PET/CT
External Beam Radiation Therapy: Undergo pelvic EBRT
Fludeoxyglucose F-18: Undergo FDG-PET/CT
High-Dose Rate Brachytherapy: Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Magnetic Resonance Imaging: Undergo MRI
Pharmacological Study: Correlative studies
Positron Emission Tomography: Undergo FDG-PET/CT
Triapine: Given IV and PO
|
|---|---|---|
|
Expansion Cohort
Did not complete treatment regimen
|
1
|
0
|
Baseline Characteristics
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Baseline characteristics by cohort
| Measure |
Triapine (100mg) + Chemoradiation)
n=17 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
Biospecimen Collection: Undergo collection of blood samples
Brachytherapy: Undergo LDR brachytherapy
Cisplatin: Given IV
Computed Tomography: Undergo FDG-PET/CT
External Beam Radiation Therapy: Undergo pelvic EBRT
Fludeoxyglucose F-18: Undergo FDG-PET/CT
High-Dose Rate Brachytherapy: Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Magnetic Resonance Imaging: Undergo MRI
Pharmacological Study: Correlative studies
Positron Emission Tomography: Undergo FDG-PET/CT
Triapine: Given IV and PO
|
Triapine (150mg) + Chemoradiation)
n=4 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
n=10 Participants
|
46.5 years
n=10 Participants
|
51.0 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
21 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Smoking History
Yes
|
5 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Smoking History
No
|
12 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Smoking History
Unknown
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Primary Site
Cervix
|
15 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Primary Site
Vagina
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Histology
adenocarcinoma
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
|
Histology
squamous cell carcinoma
|
13 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
|
Histology
adenosquamous
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage IB
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage II
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage IIA
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage IIB
|
3 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Stage
Stage lV
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage III
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage IIIB
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage IIIC
|
7 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Stage at Diagnosis
Stage IVA
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Stage
Stage l
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Stage
Stage ll
|
5 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Stage
Stage lll
|
9 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
|
ECOG
ECOG = 0
|
12 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
|
ECOG
ECOG = 1
|
5 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: All treated patients evaluable for DLTs
The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD
Outcome measures
| Measure |
All Participants
n=9 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
100 mg
|
—
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: All treated patients evaluable for DLTs
Number of patients that experienced a DLT, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLTs are defined as the following adverse events if considered at least "possibly related" to a component of the study therapy and which occur from the start of treatment until completion of EBRT, prior to initiation of brachytherapy (i.e. the first 5 weeks if no treatments are missed): Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 3 toxicity not resolved with maximal intervention to Grade 0-2 over 7 days (except alopecia and fatigue); Any nausea, vomiting, diarrhea and elevation of serum creatinine level Grade 4 toxicity; Any other non-hematologic toxicity ≥Grade 3; Any hematologic toxicity of ≥ Grade 4; Grade ≥3 dyspnea; Inability to deliver at least 20 of the scheduled 25 administrations of triapine at the planned dose, allowing for 2 weeks to make up missed radiation days. Inability to deliver
Outcome measures
| Measure |
All Participants
n=6 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=3 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Number of Patients Who Experienced a DLT
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Patients that had both PO and IV triapine PK samples
The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.
Outcome measures
| Measure |
All Participants
n=16 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=4 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Bioavailability of Triapine
|
60 percentage
Interval 16.0 to 229.0
|
54 percentage
Interval 15.0 to 200.0
|
PRIMARY outcome
Timeframe: Up to 24 hours after dosingPopulation: Treated patients for whom PK samples were able to be collected
Maximum concentration
Outcome measures
| Measure |
All Participants
n=17 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=4 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Cmax
|
476 ug/L
Standard Deviation 1.90
|
344 ug/L
Standard Deviation 1.91
|
PRIMARY outcome
Timeframe: Up to 24 hours after dosingPopulation: Treated patients for whom samples were able to be collected
Time to maximum concentration,
Outcome measures
| Measure |
All Participants
n=17 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=4 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Tmax
|
0.9 hours
Standard Deviation 3.0
|
1.5 hours
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Up to 24 hours after dosingPopulation: Treated patients for whom samples were able to be collected
Area Under the Concentration-Time Curve (AUC 0-last)
Outcome measures
| Measure |
All Participants
n=17 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=4 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
AUC
|
990 ug/L x h
Standard Deviation 2.09
|
990 ug/L x h
Standard Deviation 1.42
|
PRIMARY outcome
Timeframe: Up to 24 hours after dosingPopulation: Treated patients for whom PK samples were able to be collected
Outcome measures
| Measure |
All Participants
n=17 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=4 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Elimination Half-life (t 1/2)
|
1.5 hours
Standard Deviation 1.3
|
1.5 hours
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: At 3 months post-treatmentPopulation: Patients who received at least 3 weeks of therapy (cisplatin + triapine), and had their disease re-evaluated with a 3-month post treatment 18F-FDG-PET/CT
The mCR rate at recommended phase 2 dose, defined as a metabolic complete response on PET/CT will be defined as greater than -66% reduction in tumor FDG uptake at sites of abnormal tumor FDG uptake noted on pre-treatment FDG-PET study (considering normal cardiac or liver blood pool).
Outcome measures
| Measure |
All Participants
n=13 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=3 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate
|
62 percentage response-evaluable patients
Interval 30.0 to 86.0
|
100 percentage response-evaluable patients
Interval 32.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentPopulation: Patients who received at least 3 weeks of therapy (cisplatin + triapine) and have had their disease re-evaluated (with a 3 month post treatment PET-CT) will be considered evaluable for response. (Note: Patients who exhibit objective disease progression prior to the end of cycle 1 will also be considered evaluable.)
Clinical response at the recommended phase 2 dose per RECIST v1.1 Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
All Participants
n=13 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=3 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Clinical Overall Response Rate
Stable Disease
|
15 percentage response evaluable patient
Interval 3.0 to 50.0
|
0 percentage response evaluable patient
Interval 0.0 to 68.0
|
|
Clinical Overall Response Rate
Complete Response
|
62 percentage response evaluable patient
Interval 30.0 to 86.0
|
100 percentage response evaluable patient
Interval 32.0 to 100.0
|
|
Clinical Overall Response Rate
Partial Response
|
15 percentage response evaluable patient
Interval 3.0 to 50.0
|
0 percentage response evaluable patient
Interval 0.0 to 68.0
|
|
Clinical Overall Response Rate
Progressive Disease
|
8 percentage response evaluable patient
Interval 1.0 to 42.0
|
0 percentage response evaluable patient
Interval 0.0 to 68.0
|
SECONDARY outcome
Timeframe: Up to 4 years and 2 months from start of treatmentPopulation: Treated patients evaluable for clinical response.
Median number of months that patients survive without disease progression from end of treatment. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
All Participants
n=13 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=3 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Progression Free Survival (PFS)
|
NA months
Median not reach due to too few patients experiencing progression
|
NA months
Median not reach due to too few patients experiencing progression
|
SECONDARY outcome
Timeframe: Up to 4 years and 2 months from start of treatmentPopulation: Zero treated patients experienced the event of death.
Median number of months that patients remain alive after end of treatment.
Outcome measures
| Measure |
All Participants
n=17 Participants
Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
|
Triapine (150mg) + Chemoradiation)
n=4 Participants
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 150mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30).
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
not enough events to reach a median
|
NA months
not enough events to reach a median
|
Adverse Events
Triapine (100mg) + Chemoradiation)
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Triapine (150mg) + Chemoradiation)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triapine (100mg) + Chemoradiation)
n=17 participants at risk
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
Biospecimen Collection: Undergo collection of blood samples
Brachytherapy: Undergo LDR brachytherapy
Cisplatin: Given IV
Computed Tomography: Undergo FDG-PET/CT
External Beam Radiation Therapy: Undergo pelvic EBRT
Fludeoxyglucose F-18: Undergo FDG-PET/CT
High-Dose Rate Brachytherapy: Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Magnetic Resonance Imaging: Undergo MRI
Pharmacological Study: Correlative studies
Positron Emission Tomography: Undergo FDG-PET/CT
Triapine: Given IV and PO
|
Triapine (150mg) + Chemoradiation)
n=4 participants at risk
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Blood and lymphatic system disorders
Decreased platelets
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Cardiac disorders
Sinus tachycardia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Methemoglobinemia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Neutrophil count decreased
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
White blood cell decreased
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Nervous system disorders
Stroke
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
Other adverse events
| Measure |
Triapine (100mg) + Chemoradiation)
n=17 participants at risk
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
Biospecimen Collection: Undergo collection of blood samples
Brachytherapy: Undergo LDR brachytherapy
Cisplatin: Given IV
Computed Tomography: Undergo FDG-PET/CT
External Beam Radiation Therapy: Undergo pelvic EBRT
Fludeoxyglucose F-18: Undergo FDG-PET/CT
High-Dose Rate Brachytherapy: Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy: Undergo IMRT
Magnetic Resonance Imaging: Undergo MRI
Pharmacological Study: Correlative studies
Positron Emission Tomography: Undergo FDG-PET/CT
Triapine: Given IV and PO
|
Triapine (150mg) + Chemoradiation)
n=4 participants at risk
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
35.3%
6/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Eye disorders
Blurred vision
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Eye disorders
Flashing lights
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Bloating
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Constipation
|
29.4%
5/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Diarrhea
|
94.1%
16/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Nausea
|
88.2%
15/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
100.0%
4/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Rectal pain
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Gastrointestinal disorders
Vomiting
|
64.7%
11/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Chills
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Edema
|
23.5%
4/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Fatigue
|
76.5%
13/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
100.0%
4/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Blood and lymphatic system disorders
Decreased platelets
|
76.5%
13/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Blood and lymphatic system disorders
Luekocytosis
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Cardiac disorders
Chest pain - cardiac
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Cardiac disorders
Sinus bradycardia
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Cardiac disorders
Sinus tachycardia
|
29.4%
5/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Blood and lymphatic system disorders
Anemia
|
94.1%
16/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Blood and lymphatic system disorders
Blood bicarbonate decreased
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Fever
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Infusion related reaction
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Irritability
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Light headedness
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
General disorders
Pain
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Infections and infestations
Pelvic infection
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Infections and infestations
Shingles
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Infections and infestations
Urinary tract infection
|
23.5%
4/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Injury, poisoning and procedural complications
Bruising
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Fogginess
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Increase LDH
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Lymphocyte count decreased
|
88.2%
15/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
100.0%
4/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Methemoglobinemia
|
58.8%
10/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Neutrophil count decreased
|
76.5%
13/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Total protein decreased
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
Weight loss
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Investigations
White blood cell decreased
|
82.4%
14/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Anorexia
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.1%
8/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
29.4%
5/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
35.3%
6/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
47.1%
8/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
64.7%
11/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
70.6%
12/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.5%
4/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Nervous system disorders
Dysgeusia
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Nervous system disorders
Headache
|
29.4%
5/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Nervous system disorders
Paresthesia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Psychiatric disorders
Insomnia
|
23.5%
4/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Psychiatric disorders
Restlessness
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Bladder pain
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Bladder spasm
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Dysuria
|
47.1%
8/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Hematuria
|
35.3%
6/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
50.0%
2/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Proteinuria
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Urinary frequency
|
23.5%
4/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
75.0%
3/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Urinary pressure
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Urinary tract pain
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Renal and urinary disorders
Urinary urgency
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Reproductive system and breast disorders
Pelvic pain
|
23.5%
4/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Reproductive system and breast disorders
Perineal pain
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
23.5%
4/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Respiratory, thoracic and mediastinal disorders
Cold-like symptoms
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
3/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Skin and subcutaneous tissue disorders
Perianal sores
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Skin and subcutaneous tissue disorders
Scrape on knee
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Skin and subcutaneous tissue disorders
Skin patches
|
0.00%
0/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Flushing
|
11.8%
2/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Hot flashes
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Hypertension
|
52.9%
9/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
25.0%
1/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Small knots in vein of R leg
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
0.00%
0/4 • Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Toxicity evaluated using the NCI CTCAE version 4.0 (version 5.0 beginning April 1, 2018).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60