Trial Outcomes & Findings for Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer (NCT NCT00699491)
NCT ID: NCT00699491
Last Updated: 2018-06-13
Results Overview
The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported. Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria: * Any grade 4 hematologic toxicity * Hyperglycemia that cannot be stably controlled with diabetic medication * Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
During first course
Results posted on
2018-06-13
Participant Flow
Participant milestones
| Measure |
Dose Level 1
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
Phase II patients receive the recommended phase II dose determined in the phase I portion.
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
* 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
7
|
6
|
8
|
22
|
|
Overall Study
COMPLETED
|
3
|
2
|
7
|
6
|
8
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=2 Participants
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
n=7 Participants
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
n=6 Participants
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
n=8 Participants
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=22 Participants
Phase II patients receive the recommended phase II dose determined in the phase I portion.
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
* 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35 years
n=5 Participants
|
68 years
n=7 Participants
|
49 years
n=5 Participants
|
53 years
n=4 Participants
|
48.5 years
n=21 Participants
|
57 years
n=10 Participants
|
48.5 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
48 Participants
n=115 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
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
22 participants
n=10 Participants
|
48 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: During first coursePopulation: Patients registered to the Phase I portion of the protocol were analyzed for this endpoint. One patient in Dose Level -1, one patient in Dose Level -2, and two patients in Dose Level -2B discontinued study treatment during Cycle 1 for reasons unrelated to toxicity and were excluded from this endpoint.
The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported. Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria: * Any grade 4 hematologic toxicity * Hyperglycemia that cannot be stably controlled with diabetic medication * Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=1 Participants
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
n=6 Participants
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
n=6 Participants
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
n=6 Participants
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Recommended Dose Level for Phase II Testing (RPTD) (Phase I)
|
2 DLTs
|
1 DLTs
|
1 DLTs
|
0 DLTs
|
3 DLTs
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart. Complete Response (CR): All of the following must be true: 1. Disappearance of all target and non-target lesions. 2. Each target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures. The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach.
Outcome measures
| Measure |
Dose Level 1
n=21 Participants
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
|
0 percentage of patients with response
Interval 0.0 to 13.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients that received protocol treatment were evaluable for this endpoint.
Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be 'at least possibly related to treatment' will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported.
Outcome measures
| Measure |
Dose Level 1
n=22 Participants
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)
Grade 3+ Adverse Event
|
8 participants
|
—
|
—
|
—
|
—
|
|
Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)
Grade 4+ Adverse Event
|
1 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: No patients were eligible for this endpoint.
Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from registration to documentation of disease progression, up to 5 yearsPopulation: One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Dose Level 1
n=21 Participants
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) (Phase II)
|
2.0 months
Interval 1.5 to 3.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.
Outcome measures
| Measure |
Dose Level 1
n=21 Participants
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Progression Free Survival Rate
|
14.3 percentage of patients
Interval 5.0 to 40.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from registration to death due to any causePopulation: One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Dose Level 1
n=21 Participants
* 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
* 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
* 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
* 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Survival Time (Phase II)
|
10.1 months
Interval 4.9 to 19.1
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level -1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level -2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Level -2A
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Level -2B
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase II
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=2 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
n=7 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
n=6 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
n=8 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=22 participants at risk
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
33.3%
2/6 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Death
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Fatigue
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -1
n=2 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2
n=7 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2A
n=6 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Dose Level -2B
n=8 participants at risk
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Phase II
n=22 participants at risk
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Taste alteration
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
3/3 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
100.0%
2/2 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
71.4%
5/7 • Number of events 13
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
100.0%
6/6 • Number of events 15
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
62.5%
5/8 • Number of events 10
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
72.7%
16/22 • Number of events 42
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
22.7%
5/22 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Eye disorders
Flashing vision
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
25.0%
2/8 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
18.2%
4/22 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
42.9%
3/7 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
3/6 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
40.9%
9/22 • Number of events 17
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
3/3 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
85.7%
6/7 • Number of events 12
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
3/6 • Number of events 7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
62.5%
5/8 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
54.5%
12/22 • Number of events 21
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
28.6%
2/7 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
3/6 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
25.0%
2/8 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
45.5%
10/22 • Number of events 17
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
36.4%
8/22 • Number of events 11
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Chills
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Edema limbs
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
13.6%
3/22 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
85.7%
6/7 • Number of events 12
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
100.0%
6/6 • Number of events 16
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
75.0%
6/8 • Number of events 9
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
86.4%
19/22 • Number of events 52
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Fever
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
General disorders
Pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Immune system disorders
Hypersensitivity
|
33.3%
1/3 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
25.0%
2/8 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
18.2%
4/22 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
27.3%
6/22 • Number of events 8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
25.0%
2/8 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
31.8%
7/22 • Number of events 10
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Bilirubin increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
36.4%
8/22 • Number of events 14
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Leukocyte count decreased
|
33.3%
1/3 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
71.4%
5/7 • Number of events 8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
83.3%
5/6 • Number of events 16
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
37.5%
3/8 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
59.1%
13/22 • Number of events 32
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
28.6%
2/7 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
3/6 • Number of events 9
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
18.2%
4/22 • Number of events 9
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
71.4%
5/7 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
83.3%
5/6 • Number of events 10
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
25.0%
2/8 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
45.5%
10/22 • Number of events 24
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
100.0%
2/2 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
42.9%
3/7 • Number of events 9
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
3/6 • Number of events 7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
37.5%
3/8 • Number of events 7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
59.1%
13/22 • Number of events 30
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
33.3%
2/6 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
18.2%
4/22 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Investigations
Weight loss
|
33.3%
1/3 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
57.1%
4/7 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
33.3%
2/6 • Number of events 9
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
36.4%
8/22 • Number of events 20
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
3/3 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
42.9%
3/7 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
83.3%
5/6 • Number of events 9
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
4/8 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
63.6%
14/22 • Number of events 31
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
100.0%
3/3 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
100.0%
2/2 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
57.1%
4/7 • Number of events 11
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
100.0%
6/6 • Number of events 18
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
4/8 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
72.7%
16/22 • Number of events 39
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
33.3%
2/6 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
13.6%
3/22 • Number of events 3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
33.3%
2/6 • Number of events 7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
36.4%
8/22 • Number of events 13
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
13.6%
3/22 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
12.5%
1/8 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
9.1%
2/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
14.3%
1/7 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Atrophy skin
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
18.2%
4/22 • Number of events 8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
3/3 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
28.6%
2/7 • Number of events 4
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
22.7%
5/22 • Number of events 12
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
100.0%
3/3 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
1/2 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
57.1%
4/7 • Number of events 7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
3/6 • Number of events 8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
4/8 • Number of events 5
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
50.0%
11/22 • Number of events 20
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Vascular disorders
Flushing
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
4.5%
1/22 • Number of events 1
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
13.6%
3/22 • Number of events 6
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/7
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
16.7%
1/6 • Number of events 2
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/8
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
0.00%
0/22
All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60