Trial Outcomes & Findings for p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246 (NCT NCT03268382)
NCT ID: NCT03268382
Last Updated: 2025-03-17
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
APR-246 (4.5g/6hr) + PLD
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/3hr) +PLD
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/4hr) +PLD
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (3.7g/4hr) +PLD
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
28
|
3
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246
Baseline characteristics by cohort
| Measure |
APR-246 (4.5g/6hr) + PLD
n=28 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/3hr) + PLD
n=3 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/4hr) + PLD
n=2 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (3.7g/4hr) + PLD
n=3 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
21 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: A total of 36 patients were enrolled in this Phase II study. Of the 36 patients, 28 patients were in the main study, 4.5g/6hr dose cohort; 8 patients were in the sub-study as follows: 3 patients were in the 4.5g/3hr dose cohort; 2 patients were in the 4.5g/4hr dose cohort and 3 patients were in the 3.7g/4hr dose cohort. The 23 Efficacy Evaluable Patients from the Main Study (APR-246 (4.5g/6hr) + PLD) are part of the analysis reported below.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
APR-246 (4.5g/6hr) + PLD
n=23 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/3hr) + PLD
n=3 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/4hr) + PLD
n=2 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (3.7g/4hr) + PLD
n=3 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
Partial Response (PR)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate (ORR)
Stable Disease (SD)
|
15 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Overall Response Rate (ORR)
Progressive Disease (PD)
|
7 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Overall Response Rate (ORR)
Not Evaluable
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate (ORR)
Disease Control Rate (CR+PR+SD)
|
16 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. AEs were graded according to NCI CTCAE (Version 4.0). Patients with multiple TEAEs were only counted once within a summary category: SOC, PT, maximum grade, or relationship to treatment. Patients with events in more than one category were counted once within each category.
Outcome measures
| Measure |
APR-246 (4.5g/6hr) + PLD
n=28 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/3hr) + PLD
n=3 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/4hr) + PLD
n=2 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (3.7g/4hr) + PLD
n=3 Participants
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
|---|---|---|---|---|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With Any Treatment-Emergent Adverse Events (TEAEs)
|
28 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With APR-246 Related TEAEs
|
25 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With PLD Related TEAEs
|
24 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With Severity Grade >=3
|
14 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With Severity Grade >=3 APR-246 Related TEAEs
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With Severity Grade >=3 PLD Related TEAEs
|
7 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With Any Serious AEs
|
11 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With Any Serious, APR-246 Related AEs
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
With Any Serious, PLD Related AEs
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
Who Discontinued APR-246 Due to TEAEs
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
Who Discontinued PLD Due to TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Adverse Events With Combined APR-246 and PLD Regimen
Who Died Due to any TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
APR-246 (4.5g/6hr) + PLD
Serious events: 11 serious events
Other events: 28 other events
Deaths: 9 deaths
APR-246 (4.5g/3hr) + PLD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
APR-246 (4.5g/4hr) + PLD
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
APR-246 (3.7g/4hr) + PLD
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
APR-246 (4.5g/6hr) + PLD
n=28 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/3hr) + PLD
n=3 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/4hr) + PLD
n=2 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (3.7g/4hr) + PLD
n=3 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
10.7%
3/28 • Number of events 3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Peritoneal fibrosis
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Device related infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Ataxia
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Number of events 2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Number of events 6 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Mucosal inflammation
|
3.6%
1/28 • Number of events 3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Renal and urinary disorders
Renal failure
|
3.6%
1/28 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
Other adverse events
| Measure |
APR-246 (4.5g/6hr) + PLD
n=28 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/3hr) + PLD
n=3 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (4.5g/4hr) + PLD
n=2 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
APR-246 (3.7g/4hr) + PLD
n=3 participants at risk
APR-246: Intravenous infusion Pegylated Liposomal Doxorubicin Hydrochloride (PLD): Intravenous infusion
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
60.7%
17/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
66.7%
2/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
3/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
12/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
66.7%
2/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
2/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
3/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Constipation
|
39.3%
11/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
66.7%
2/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Abdominal pain
|
32.1%
9/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
3/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
6/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
66.7%
2/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Abdominal distension
|
10.7%
3/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
66.7%
2/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Fatigue
|
21.4%
6/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
3/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
3/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Asthenia
|
35.7%
10/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Mucosal inflammation
|
25.0%
7/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Edema peripheral
|
14.3%
4/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Gait disturbance
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Device occlusion
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
66.7%
2/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Infusion site vesicles
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Dizziness
|
17.9%
5/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
2/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Dysgeusia
|
10.7%
3/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Ataxia
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Dyskinesia
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Neuropathy peripheral
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Tremor
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
66.7%
2/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Akathisia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Apraxia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
6/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
4/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
7/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
100.0%
3/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
4/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Urinary tract infection
|
10.7%
3/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Conjunctivitis
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Device related infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Lip infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.9%
5/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
3/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Psychiatric disorders
Irritability
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
50.0%
1/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Vascular disorders
Vascular disorders
|
10.7%
3/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Immune system disorders
Hypersensitivity
|
3.6%
1/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Eye disorders
Blepharitis
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
33.3%
1/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Ascites
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
General disorders
Pyrexia
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
2/28 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/2 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
0.00%
0/3 • Treatment emergent adverse events (TEAEs) were defined as AEs that occurred on or after the first dose of study medication up to and including 30 days after last dose. Median number of 28d Cycles=2.5 (Min = 1, Max = 14)
AEs were graded according to NCI CTCAE (Version 4.0).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place