Trial Outcomes & Findings for Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer (NCT NCT02154529)
NCT ID: NCT02154529
Last Updated: 2022-04-27
Results Overview
Percentage of subjects with at least 1 treatment-emergent adverse event of Grade 3 or greater or relationship with tesevatinib. TEAE grading was by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) where Grade 3 is severe and Grade 4 is life-threatening. TEAEs were considered related to study drug if the investigator assessed them as possibly related, probably related, or related.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 8 months: 1 month (28 days) Screening + 6 months treatment + 1 month follow-up
Results posted on
2022-04-27
Participant Flow
Open-label, ascending-dose
Participant milestones
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
8
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
8
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
5
|
1
|
|
Overall Study
Termination of study by sponsor
|
2
|
2
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=4 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=8 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
n=2 Participants
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 8.66 • n=39 Participants
|
50.3 years
STANDARD_DEVIATION 7.23 • n=41 Participants
|
51.0 years
STANDARD_DEVIATION 8.80 • n=35 Participants
|
59.5 years
STANDARD_DEVIATION 2.12 • n=31 Participants
|
49.4 years
STANDARD_DEVIATION 9.48 • n=146 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Childbearing potential
Yes
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Childbearing potential
No
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Up to 8 months: 1 month (28 days) Screening + 6 months treatment + 1 month follow-upPopulation: All subjects who received at least 1 dose of study drug
Percentage of subjects with at least 1 treatment-emergent adverse event of Grade 3 or greater or relationship with tesevatinib. TEAE grading was by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) where Grade 3 is severe and Grade 4 is life-threatening. TEAEs were considered related to study drug if the investigator assessed them as possibly related, probably related, or related.
Outcome measures
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=4 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=8 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
n=2 Participants
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
n=17 Participants
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib
Grade ≥ 3
|
1 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
9 Participants
|
|
Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib
Related to Tesevatinib
|
4 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
16 Participants
|
|
Safety and Tolerability: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) by Severity and/or Relationship to Tesevatinib
Grade ≥ 3 Related to Tesevatinib
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 8 months: 1 month (28 days) Screening + 6 months treatment + 1 month follow-upPopulation: All subjects who received at last 1 dose of study drug
Percentage of subjects with at least 1 serious adverse event considered related to study drug. SAEs were considered related to tesevatinib drug if the investigator assessed them as possibly related, probably related, or related.
Outcome measures
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=4 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=8 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
n=2 Participants
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
n=17 Participants
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Safety and Tolerability: Percentage of Subjects With Serious Adverse Event (SAE) Related to Tesevatinib
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1Population: Subjects who completed at least 1 cycle of study drug and had PK (pharmacokinetics) measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150 mg tesevatinib PO (by mouth) QD(once daily) / 6 mg/kg trastuzumab IV every 3 weeks. Note: Subjects in Cohort 350 mg tesevatinib received only 8 mg/kg trastuzumab and so were not included in this analysis.
The mean of the maximum serum concentration (Cmax) for the combination of tesevatinib and trastuzumab after 1 cycle (Cycle 2 Day 1).
Outcome measures
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=7 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Mean Serum Cmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab
|
276 ng/mL
Standard Deviation 84.4
|
614 ng/mL
Standard Deviation 261
|
394 ng/mL
Standard Deviation 177
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1Population: Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib received only 8 mg/kg trastuzumab and so were not included in this analysis.
The median time of the maximum serum concentration (Tmax) for the combination of tesevatinib and trastuzumab after 1 cycle (Cycle 2 Day 1)
Outcome measures
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=7 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Median Serum Tmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab
|
4.00 hours
Interval 3.97 to 4.0
|
5.98 hours
Interval 4.05 to 8.0
|
6.00 hours
Interval 3.93 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1Population: Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib received 8 mg/kg trastuzumab and so were not included in this analysis.
The mean area under the concentration-time curve during the period from 0 to a given time point 't' in the tesevatinib 150 mg QD, 250 mg QD, and 300 mg QD cohorts.
Outcome measures
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=7 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Mean Serum AUC(0-t) (Area Under Curve) of Treatment With Tesevatinib + Trastuzumab
|
5120 hr*ng/mL
Standard Deviation 1530
|
13000 hr*ng/mL
Standard Deviation 5750
|
8200 hr*ng/mL
Standard Deviation 3390
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1Population: Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib only received 8 mg/kg trastuzumab and so were not included in this analysis.
The mean of the arithmetic mean accumulation ratio (AR) of the maximum concentration of tesevatinib. The AR is defined as: Cmax for Cycle 2 divided by Cmax of Cycle 1.
Outcome measures
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=7 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Mean AR Cmax After 1 Cycle of Treatment With Tesevatinib + Trastuzumab
|
3.46 ratio (no units)
Standard Deviation 1.11
|
3.38 ratio (no units)
Standard Deviation 0.993
|
2.21 ratio (no units)
Standard Deviation 1.38
|
—
|
—
|
SECONDARY outcome
Timeframe: PK samples taken pre-dose, and 1, 2, 4, 6, 8, and 24 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1Population: Subjects who completed at least 1 cycle of study drug and had PK measurements performed on Cycle 2 Day 1. Stratified by tesevatinib dose level, not by initial 8 mg/kg trastuzumab dosing level, i.e., 150, 250, and 300 mg tesevatinib with 6 mg/kg trastuzumab. Note: Subjects in Cohort 350 mg tesevatinib received only 8 mg/kg trastuzumab and so were not included in this analysis.
The mean of the arithmetic mean accumulation ratio (AR) of the area under the concentration-time curve from 0 to 24 hours. The AR is defined as: AUC(0-24hr) for Cycle 2 divided by AUC(0-24hr) for Cycle 1.
Outcome measures
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 Participants
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=7 Participants
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Mean AR AUC(0-24hr) After 1 Cycle of Treatment With Tesevatinib + Trastuzumab
|
4.04 ratio (no units)
Standard Deviation 0.762
|
4.23 ratio (no units)
Standard Deviation 1.17
|
2.80 ratio (no units)
Standard Deviation 1.33
|
—
|
—
|
Adverse Events
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
Serious events: 5 serious events
Other events: 8 other events
Deaths: 5 deaths
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
All Patients
Serious events: 7 serious events
Other events: 17 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=4 participants at risk
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzunab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 participants at risk
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzunab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=8 participants at risk
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
n=2 participants at risk
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
n=17 participants at risk
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
25.0%
2/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
17.6%
3/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Brain edema
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Metastases to Central Nervous System
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Blood bilirubin incrased
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Transaminase increased
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
Other adverse events
| Measure |
Arm 1: Tesevatinib 150 mg PO QD + Trastuzumab 8 mg/kg IV
n=4 participants at risk
Tesevatinib 150 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzunab every 3 weeks
|
Arm 2: Tesevatinib 250 mg PO QD + Trastuzumab 8 mg/kg IV
n=3 participants at risk
Tesevatinib 250 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzunab every 3 weeks
|
Arm 3: Tesevatinib 300 mg PO QD + Trastuzumab 8 mg/kg IV
n=8 participants at risk
Tesevatinib 300 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
Arm 4: Tesevatinib 350 mg PO QD + Trastuzumab 8 mg/kg IV
n=2 participants at risk
Tesevatinib 350 mg orally administered once daily in combination with Trastuzumab IV 8 mg/kg initially then 6 mg/kg trastuzumab every 3 weeks
|
All Patients
n=17 participants at risk
Combination of subjects in Cohorts 1, 2, 3, and 4
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
66.7%
2/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
37.5%
3/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
41.2%
7/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
100.0%
2/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
29.4%
5/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
50.0%
2/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
100.0%
3/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
37.5%
3/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
52.9%
9/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
37.5%
3/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
29.4%
5/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
25.0%
2/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
23.5%
4/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
17.6%
3/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
66.7%
2/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
87.5%
7/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
100.0%
2/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
82.4%
14/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
37.5%
3/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
29.4%
5/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Gastrointestinal disorders
Catheter site erythema
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Chills
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Face edema
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Influenza-like illness
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Pain
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
General disorders
Temperature intolerance
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Amylase increased
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Blood bilirubin incrased
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
37.5%
3/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
100.0%
2/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
35.3%
6/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
25.0%
2/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
17.6%
3/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
25.0%
2/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
17.6%
3/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
17.6%
3/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Brain edema
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Metastases to Central Nervous System
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Infections and infestations
Nail infection
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
33.3%
1/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
11.8%
2/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Blood and lymphatic system disorders
Anemia vitamin B12 deficiency
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
50.0%
1/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/4 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/3 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
12.5%
1/8 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
0.00%
0/2 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
5.9%
1/17 • Assessed up to 8 months: 1 month screening + 6 months treatment + 1 month follow-up
The Medical Dictionary of Regulatory Activities Summary of Classifications and Preferred Terms was used to describe AEs. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; Version 4.03) was used for grading toxicities. Serious adverse events included those with Grade 4, life-threatening.
|
Additional Information
Associate Vice President, Clinical Operations
Kadmon Corporation
Phone: 833-900-5366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results. The sponsor cannot require changes to the study results in the communication except to remove sponsor's confidential information. Sponsor cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER