Trial Outcomes & Findings for L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (NCT NCT02834403)
NCT ID: NCT02834403
Last Updated: 2023-12-15
Results Overview
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2. As patients are accrued, a standard Bayesian model averaging continual reassessment method (CRM) approach will be used to determine the appropriate dosage. For a dose level to be chosen as the MTD, at least 4 patients must have received said dose without experiencing a significant number of DLTs based on the Bayesian Model Averaging Continual Reassessment Method.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
DLTs assessment window is the duration required for completing one full cycle (through Day 21).
Results posted on
2023-12-15
Participant Flow
2 subjects withdrew in phase 2 and were in-evaluable.
Participant milestones
| Measure |
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 7.5 mg/kg (starting dose) will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
3
|
4
|
22
|
|
Overall Study
Evaluable Patients
|
2
|
2
|
2
|
2
|
3
|
4
|
20
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
1
|
3
|
3
|
18
|
Reasons for withdrawal
| Measure |
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 7.5 mg/kg (starting dose) will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
2
|
1
|
1
|
2
|
12
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Complete response before the end of 6 cycles
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 7.5 mg/kg (starting dose) will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
n=3 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
n=4 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
n=20 Participants
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55 Years
n=5 Participants
|
51.5 Years
n=7 Participants
|
62 Years
n=5 Participants
|
65 Years
n=4 Participants
|
64 Years
n=21 Participants
|
63 Years
n=10 Participants
|
55 Years
n=115 Participants
|
58 Years
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
35 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Non-Hispanic Caucasian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
19 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic Caucasian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Stage of Breast Cancer Diagnosis
Metastatic breast cancer
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
|
Stage of Breast Cancer Diagnosis
Locally advanced breast cancer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: DLTs assessment window is the duration required for completing one full cycle (through Day 21).Population: 15 participants participated in Phase Ib portion of the trial until the MTD was determined after 4 patient completed at least one cycle of treatment at the same dose without DLTs.
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2. As patients are accrued, a standard Bayesian model averaging continual reassessment method (CRM) approach will be used to determine the appropriate dosage. For a dose level to be chosen as the MTD, at least 4 patients must have received said dose without experiencing a significant number of DLTs based on the Bayesian Model Averaging Continual Reassessment Method.
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
n=15 Participants
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Asses the Maximum Tolerated Dose (MTD) of L-NMMA When Combined With Docetaxel/Amlodipine in the Treatment of Refractory Locally Advanced or Metastatic TNBC Patients, Based on the Number of Dose Limiting Toxicities (DLTs) Per Dose Level.
|
20 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: The approximate length of the study from Cycle 1, Day 1 will be approximately seven months (approximately four months of treatment plus three months of follow-up).Population: 24 subjects participated in the Phase II portion of the trial
Primary Outcome Measure for Phase II: Determine the number of participants with complete response, partial response, or stable disease after 6 cycles of L-NMMA combined with taxane chemotherapy (docetaxel, paclitaxel, or nab-paclitaxel)/amlodipine, as assessed by the RECIST 1.1. * CR (complete response) = disappearance of all target lesions * PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions * PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions * SD (stable disease) = small changes that do not meet above criteria * Treatment Failure: taken off the study because of adverse events before the first restaging scan after cycle 2
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
n=24 Participants
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate
Metastatic breast cancer · Complete Response
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Metastatic breast cancer · Partial Response
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Metastatic breast cancer · Stable Disease
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Metastatic breast cancer · Progressive Disease
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Metastatic breast cancer · Treatment Failure
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Locally advanced breast cancer · Complete Response
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Locally advanced breast cancer · Partial Response
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Locally advanced breast cancer · Stable Disease
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Locally advanced breast cancer · Progressive Disease
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Benefit Rate
Locally advanced breast cancer · Treatment Failure
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: DLTs assessment window is the duration required for completing one full cycle (through Day 21).Population: 15 participants participated in Phase Ib portion of the trial until the MTD was determined after 4 patient completed at least one cycle of treatment at the same dose without DLTs.
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2. As patients are accrued, a standard Bayesian model averaging continual reassessment method (CRM) approach will be used to determine the appropriate dosage. For a dose level to be chosen as the MTD, at least 4 patients must have received said dose without experiencing a significant number of DLTs based on the Bayesian Model Averaging Continual Reassessment Method.
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
n=15 Participants
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Asses the Maximum Tolerated Dose (MTD) of Docetaxel When Combined With L-NMMA/Amlodipine in the Treatment of Refractory Locally Advanced or Metastatic TNBC Patients, Based on the Number of Dose Limiting Toxicities (DLTs) Per Dose Level.
|
100 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The approximate length of the study from Cycle 1, Day 1 will be approximately seven months (approximately four months of treatment plus three months of follow-up).Population: Patients who experienced adverse events Grade ≥ 3
Describe the DLTs and other adverse events associated with L-NMMA when combined with docetaxel/amlodipine, as assessed by the CTCAE v4.03 Any Grade ≥ 3 Adverse Events (AE) unless there is clear alternative evidence that the AE was not caused by the study treatment.
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
n=1 Grade ≥ 3 AE
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
n=7 Grade ≥ 3 AE
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
n=3 Grade ≥ 3 AE
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
n=3 Grade ≥ 3 AE
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Constitutional
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
2 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Peripheral neuropathy
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Dermatological
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Infectious
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Renal
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Elevation of AST/ALT
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Dehydration
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Gastric
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Cardiac
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
2 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
|
Dose Limiting Toxicities (DLTs) and Other Adverse Events
Vascular
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
1 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
0 Grade ≥ 3 AE
|
SECONDARY outcome
Timeframe: The Dose Limiting Toxicities (DLT) assessment window is the duration required for completing one full cycle (through Day 21).Population: 15 participants participated in Phase Ib portion of the trial until the MTD was determined after 4 patient completed at least one cycle of treatment at the same dose without DLTs.
Determine the RP2D of the L-NMMA and docetaxel combination based on the occurrence of DLTs during Phase Ib portion of the study. As patients are accrued, they will start with 7.5 mg/kg of L-NMMA and 75 mg/m2 of docetaxel and their DLTs will be assessed after completion of the first cycle. This will determine the next cohort dose, until at least 4 patients receive the dose with minimal DLTs that won't require dose reduction.
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
n=15 Participants
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) of the L-NMMA and Docetaxel Combination
|
20 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The approximate length of the study from Cycle 1, Day 1 will be approximately seven months (approximately four months of treatment plus three months of follow-up).Population: 22 subjects participated in the Phase II portion of the trial (2 patients were in-evaluable) 4 subjects were included from Phase Ib portion who received the same dose.
Assess the antitumor activity of L-NMMA when combined with taxane chemotherapy (docetaxel, paclitaxel, or nab-paclitaxel)/amlodipine, as assessed by the RECIST 1.1. * CR (complete response) = disappearance of all target lesions * PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions * PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions * SD (stable disease) = small changes that do not meet above criteria * Treatment Failure: taken off the study because of adverse events before the first restaging scan after cycle 2
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
n=2 Participants
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
n=3 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
n=4 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
n=20 Participants
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Antitumor Activity
Partial Response (<100% reduction)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
|
Antitumor Activity
Complete Response (100% reduction)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Antitumor Activity
Treatment Failure
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Antitumor Activity
Stable Disease (< 20% change)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antitumor Activity
Progressive Disease (> 20% growth)
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Blood samples will be collected predose (10-30 minutes before L-NMMA infusion) on Days 1, 2, and 5 of Cycle 1 and Days 1 and 5 of Cycle 2 for determination of L-NMMA plus docetaxel plasma PK.Population: To determine the PK of L-NMMA, we assayed serum samples from two patients receiving L-NMMA at 15 mg/kg and docetaxel at 75 mg/m2 and two patients receiving L-NMMA at 17.5 mg/kg and docetaxel at 100 mg/m2.
Determine the time to maximum plasma concentration of the L-NMMA and docetaxel combination.
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
n=2 Participants
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
n=2 Participants
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration of L-NMMA and Docetaxel
Tmax for LNMMA
|
2 Hours
Interval 0.0 to 24.0
|
2 Hours
Interval 0.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Plasma Concentration of L-NMMA and Docetaxel
Tmas for Docetaxel
|
4 Hours
Interval 0.0 to 30.0
|
4 Hours
Interval 0.0 to 30.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The Dose Limiting Toxicities (DLT) assessment window is the duration required for completing one full cycle (through Day 21).Population: 15 participants participated in Phase Ib portion of the trial until the MTD was determined after 4 patient completed at least one cycle of treatment at the same dose without DLTs.
Determine the RP2D of the L-NMMA and docetaxel combination based on the occurrence of DLTs during Phase Ib portion of the study. As patients are accrued, they will start with 7.5 mg/kg of L-NMMA and 75 mg/m2 of docetaxel and their DLTs will be assessed after completion of the first cycle. This will determine the next cohort dose, until at least 4 patients receive the dose with minimal DLTs that won't require dose reduction.
Outcome measures
| Measure |
Phase Ib - Dose Finding - L-NMMA
n=15 Participants
The Phase Ib portion of the study is designed to investigate the combination at two dose levels of docetaxel (75 and 100 mg/m2) and 7 dose levels of L-NMMA (5, 7.5, 10, 12.5, 15, 17.5, and 20 mg/kg). The starting dose will be L-NMMA at 7.5 mg/kg and docetaxel at 75 mg/m2.
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study.
|
|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) of the L-NMMA and Docetaxel Combination
|
100 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 weeksDetermine the area under the plasma concentration curve of the L-NMMA and docetaxel combination
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 weeksDetermine potential predictive biomarkers including serum levels of nitrate/nitrite; serum levels of inflammatory biomarkers; angiogenesis-related biomarkers; and RPL39, MLF2, and phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutations in cell-free DNA
Outcome measures
Outcome data not reported
Adverse Events
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Experimental: Phase II: RP2D Determined in the Phase Ib
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 7.5 mg/kg (starting dose) will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
Amlodipine: Long-acting calcium channel blocker
Pegfilgrastim: Colony-stimulating factor
Enteric-coated aspirin: non-steroidal anti-inflammatory drug
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
n=3 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
n=4 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
n=20 participants at risk
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Change in mental status
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Right upper extremity Cellulitis
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Renal and urinary disorders
Acute renal insufficiency
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Cardiac disorders
Chest wall significant Erythema on front and back
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Clinical sepsis
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
Other adverse events
| Measure |
Experimental: L-NMMA 7.5 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 7.5 mg/kg (starting dose) will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
Amlodipine: Long-acting calcium channel blocker
Pegfilgrastim: Colony-stimulating factor
Enteric-coated aspirin: non-steroidal anti-inflammatory drug
|
Experimental: L-NMMA 10 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 10 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 12.5 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 12.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 15 mg/kg and Docetaxel 75 mg/m2
n=2 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 15 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 75 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 17.5 mg/kg and Docetaxel 100 mg/m2
n=3 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 17.5 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: L-NMMA 20 mg/kg and Docetaxel 100 mg/m2
n=4 participants at risk
Phase Ib: L-NMMA and docetaxel will be given for 6 21-day cycles. L-NMMA at doses of 20 mg/kg will be administered IV on Days 1-5. Docetaxel will be administered at 100 mg/m2 as an IV 15 min after L-NMMA infusion Day 1.
|
Experimental: Phase II: RP2D Determined in the Phase Ib
n=20 participants at risk
Phase II: L-NMMA starting dose will be the RP2D determined in the Phase Ib portion of the study
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Immune system disorders
Acute allergic reaction
|
50.0%
1/2 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Pain
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
35.0%
7/20 • Number of events 7 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Cardiac disorders
Chest pain
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
10.0%
2/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Blood and lymphatic system disorders
Contusion
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
10.0%
2/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
30.0%
6/20 • Number of events 7 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
10.0%
2/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
General disorders
Edema
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Hepatobiliary disorders
Elevated AST and ALT
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
10.0%
2/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
General disorders
Fatigue and weakness
|
50.0%
1/2 • Number of events 3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
66.7%
2/3 • Number of events 4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
5/20 • Number of events 6 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Gum bleeding
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Hand-foot Syndrome
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
15.0%
3/20 • Number of events 3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Gastrointestinal disorders
Heartburn
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Eye disorders
Blepharitis
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
40.0%
8/20 • Number of events 8 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
General disorders
Arm and shoulder swelling
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
General disorders
Lower abdomen incision packing
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Renal and urinary disorders
Narrowing of brachiocephalic vein stenosis
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
10.0%
2/20 • Number of events 3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Oral mucositis
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
15.0%
3/20 • Number of events 3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
10.0%
2/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Nervous system disorders
Sensitivity to light
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
33.3%
1/3 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Hepatobiliary disorders
Transaminitis
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Urinary Tract Infection
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/20 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Infections and infestations
Vaginal candidiasis
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
66.7%
2/3 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
Metabolism and nutrition disorders
Weight loss
|
50.0%
1/2 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
25.0%
1/4 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
5.0%
1/20 • Number of events 1 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
|
General disorders
Fever
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/3 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
0.00%
0/4 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
10.0%
2/20 • Number of events 2 • From informed consent signing up to and including 30 days after the last treatment dose. All patients will be followed for 3 months after the final dose of treatment and will be evaluated accordingly with the required standard of care labs and tests. All reported events are included when the subjects was on study, or within the follow up period, up to 3 months after the final dose. A maximum duration of 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place