Trial Outcomes & Findings for Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel (NCT NCT02684461)
NCT ID: NCT02684461
Last Updated: 2022-06-03
Results Overview
Overall survival is defined as the time from day 1 of treatment to death from any cause. Median overall survival was calculated for each arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 60 months
Results posted on
2022-06-03
Participant Flow
Participant milestones
| Measure |
Arm A: Sequential Consolidation
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Sequential Consolidation
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
Baseline Characteristics
Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel
Baseline characteristics by cohort
| Measure |
Arm A: Sequential Consolidation
n=7 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=6 Participants
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
6 participants
n=206 Participants
|
20 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: All subjects who received at least one dose of treatment were included.
Overall survival is defined as the time from day 1 of treatment to death from any cause. Median overall survival was calculated for each arm.
Outcome measures
| Measure |
Arm A: Sequential Consolidation
n=7 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=6 Participants
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Overall Survival
|
27.6 months
Interval 1.7 to
insufficient number of events to calculate upper limit
|
12.7 months
Interval 4.4 to
insufficient number of events to calculate upper limit
|
NA months
Lack of events to calculate median, upper limit and lower limit
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: All subjects who received at least one dose of treatment were included.
PFS is defined as the time from first day of treatment until disease progression as defined by the response evaluation criteria in solid tumors (RECIST 1.1) and and Immune Related Response Criteria (irRC), or death from any cause death or progression. RECIST 1.1 Progressive Disease (PD): \>= 20% increase in the sum of the LD of the target lesions, Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Nonprogressive disease (NPD): No measurable disease at the entrance of the study or otherwise non measurable disease will be assessed for progression. irRC Progressive Disease (irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir; for no new non-target or (irNN) and where irPR or irPD are confirmed by a repeat, consecutive assessment no less than 4 weeks later.
Outcome measures
| Measure |
Arm A: Sequential Consolidation
n=7 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=6 Participants
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
10.1 months
Interval 1.5 to
insufficient number of events to calculate upper limit
|
8.4 months
Interval 1.2 to 9.0
|
10.2 months
Interval 5.1 to
insufficient number of events to calculate upper limit
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Subjects received assigned treatment arm were included.
ORR is defined as the number of subjects with complete response + partial response based on RECIST 1.1 and irRC criteria. RECIST 1.1 Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter (LD) of target lesions. irRC Complete Response (irCR): Disappearance of all lesions, no new lesions, lymph nodes \< 10 mm in short axis, Partial Response (irPR): ≥30% decrease in the sum of target lesions and non-target lesions are irNN.
Outcome measures
| Measure |
Arm A: Sequential Consolidation
n=5 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=6 Participants
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Overall Rates of Response (ORR)
Complete response
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Overall Rates of Response (ORR)
Partial response
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Overall Rates of Response (ORR)
Stable disease
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Overall Rates of Response (ORR)
Progressive disease
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The subject who is in arm A or Arm B, and received at least 1 dose of study treatment were included.
Rates of Response is defined percent tumor size reduction based RECIST1.1 and irRC criteria (the latter if applicable) after each component of therapy in Arm A and Arm B.
Outcome measures
| Measure |
Arm A: Sequential Consolidation
n=5 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Rates of Response in Arm A and Arm B
Progressive Disease
|
1 Participants
|
1 Participants
|
—
|
|
Rates of Response in Arm A and Arm B
Stable Disease
|
2 Participants
|
3 Participants
|
—
|
|
Rates of Response in Arm A and Arm B
Complete Response
|
1 Participants
|
0 Participants
|
—
|
|
Rates of Response in Arm A and Arm B
Partial Response
|
1 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants received any dose of the study treatment.
The toxicity profile is classified and defined by both provider and the participants reported outcomes. Clinician assessed toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) Participants assessed toxicity will be classified based on the Patient-Reported Outcome version of the CTCAE (PRO-CTCAE). Adverse events occurring in greater than two patients or any grade 3 toxicity were included.
Outcome measures
| Measure |
Arm A: Sequential Consolidation
n=7 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=6 Participants
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Toxicity Profile
Creatinine Increased · Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Creatinine Increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Creatinine Increased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Adrenal insufficiency · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Adrenal insufficiency · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Atrial fibrillation · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Atrial fibrillation · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Diarrhea · Grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Toxicity Profile
Diarrhea · Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Diarrhea · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Alopecia · Grade 1
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Toxicity Profile
Alopecia · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Profile
Alopecia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Anemia · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Anemia · Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Anemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Anorexia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Anorexia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Paresthesia · Grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Toxicity Profile
White Blood Cell Decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Alkaline Phosphatase Increased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Alkaline Phosphatase Increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Alkaline Phosphatase Increased · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Dehydration · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Dehydration · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Dehydration · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Neutrophil count decreased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Neutrophil count decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Neutrophil count decreased · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Pain · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Alanine aminotransferase increased · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Alanine aminotransferase increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Hyperglycemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Hyperglycemia · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Profile
Dyspnea · Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Dyspnea · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Dyspnea · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Adrenal insufficiency · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Atrial fibrillation · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Anorexia · Grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Toxicity Profile
Paresthesia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Paresthesia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Peripheral Sensory Neuropathy · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Peripheral Sensory Neuropathy · Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity Profile
Peripheral Sensory Neuropathy · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
White Blood Cell Decreased · Grade 1
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Toxicity Profile
White Blood Cell Decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Pain · Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Toxicity Profile
Pain · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Toxicity Profile
Alanine aminotransferase increased · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Toxicity Profile
Hyperglycemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of Treatment (up to 210 Days)Population: All participants received any dose of study treatment and responded Functional assessment of Cancer Therapy-Lung questionnaires at the baseline and end of treatment (EOT)
Changes in QOL score for each subject are defined as the difference between the baseline, and at end of treatment. QOL will be evaluated using The Functional Assessment of Cancer Therapy-Lung (FACT-Lung) scale at baseline and the end of treatment. The FACT-L is the FACT-G and a lung cancer-specific (LCS) subscale given at baseline and end of treatment. The FACT-G is a 27-item measure of general QOL assessing function in 4 domains: physical well-being, social-family well-being, emotional well-being, and functional well-being. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Outcome measures
| Measure |
Arm A: Sequential Consolidation
n=5 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=4 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=5 Participants
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Quality of Life (QOL) End of Treatment
FACT- L Score Decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Quality of Life (QOL) End of Treatment
FACT- L Score Increased
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Quality of Life (QOL) End of Treatment
FACT- L Score did not Change
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 7 weeks (40-50 Days)Population: All participants received any dose of study treatment and responded Functional assessment of Cancer Therapy-Lung questionnaires at the baseline and end of treatment (EOT)
Changes in QOL score for each subject are defined as the difference between the baseline, and at 7 weeks. QOL will be evaluated using The Functional Assessment of Cancer Therapy-Lung (FACT-Lung) scale at baseline and 7 weeks. The FACT-L is the FACT-G and a lung cancer-specific (LCS) subscale given at baseline and at end of treatment. The FACT-G is a 27-item measure of general QOL assessing function in 4 domains: physical well-being, social-family well-being, emotional well-being, and functional well-being. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Outcome measures
| Measure |
Arm A: Sequential Consolidation
n=4 Participants
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=5 Participants
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=5 Participants
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Quality of Life (QOL) 7 Weeks
FACT- L Score Increased
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Quality of Life (QOL) 7 Weeks
FACT- L Score did not Change
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Quality of Life (QOL) 7 Weeks
FACT- L Score Decreased
|
1 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Arm A: Sequential Consolidation
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Arm B: Sequential Consolidation
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Arm C: Concurrent Consolidation
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Sequential Consolidation
n=7 participants at risk
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 participants at risk
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=6 participants at risk
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Number of events 7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
General disorders
General disorders and administration site conditions
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Number of events 7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
Other adverse events
| Measure |
Arm A: Sequential Consolidation
n=7 participants at risk
Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm B: Sequential Consolidation
n=7 participants at risk
Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
Arm C: Concurrent Consolidation
n=6 participants at risk
Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles
Pembrolizumab: Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
85.7%
6/7 • Number of events 7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
50.0%
3/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Endocrine disorders
Adrenal insufficiency
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Eye disorders
Blurred vision
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Eye disorders
Dry eye
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Eye disorders
Eye disorders - Other, specify
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Eye disorders
Glaucoma
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
General disorders
Edema limbs
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
General disorders
Fatigue
|
85.7%
6/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
57.1%
4/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
66.7%
4/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
General disorders
Fever
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
General disorders
Malaise
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
General disorders
Pain
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
50.0%
3/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Immune system disorders
Allergic reaction
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Infections and infestations
Gum infection
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Infections and infestations
Rhinitis infective
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
50.0%
3/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Cholesterol high
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Creatinine increased
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Lymphocyte count decreased
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
71.4%
5/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Neutrophil count decreased
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Investigations
White blood cell decreased
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
57.1%
4/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Nervous system disorders
Aphonia
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Nervous system disorders
Dysgeusia
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Psychiatric disorders
Depression
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Reproductive system and breast disorders
Bronchopulmonary hemorrhage
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
4/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
42.9%
3/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
57.1%
4/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
50.0%
3/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
33.3%
2/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
16.7%
1/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
85.7%
6/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
50.0%
3/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/7 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
0.00%
0/6 • Adverse events are collected from the first day of the study treatment through 30 days following cessation of treatment (Up to 196 days). Serious AE Collection Time Frame: From the first day of the study treatment through 90 days following cessation of treatment (Up to 256 days).
National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) used for adverse events grading.
|
Additional Information
Melahat Canter
University of North Carolina Lineberger Comprehensive Cancer Center
Phone: (919) 962-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60