Trial Outcomes & Findings for Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT02595892)
NCT ID: NCT02595892
Last Updated: 2025-08-26
Results Overview
PFS was summarized using Kaplan-Meier analyses and compared between the two arms using the logrank test. Additionally, PFS was analyzed using a Cox Proportional Hazards Model, including the stratification factor, and will be used to estimate the hazard ratio of the gemcitabine hydrochloride (gemcitabine)/ataxia telangiectasia mutated and Rad3-related (ATR) kinase inhibitor M6620 (formerly VX-970) arm relative to the gemcitabine alone arm and the associated 90% confidence interval. Disease progression, per protocol, is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Number of days from the day the subject received the first dose of protocol therapy to the date of documented progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death (regardless of cause), assessed up to 3 years
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Arm I (Gemcitabine Hydrochloride)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
Number of Participants From Arm I Who Crossed-over to Arm II
|
15
|
0
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 Years
n=5 Participants
|
60.9 Years
n=7 Participants
|
63.7 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
The Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Stage at Diagnosis
II
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Stage at Diagnosis
III
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Stage at Diagnosis
IV
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Stage at Diagnosis
Unknown
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Previous Therapy Lines
1
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Previous Therapy Lines
2
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Previous Therapy Lines
3
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Previous Therapy Lines
4
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Previous Therapy Lines
5
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Previous Therapy Lines
8
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Previous Therapy Lines in Platinum Resistant Setting
1
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Previous Therapy Lines in Platinum Resistant Setting
0
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Previous Poly Adenosine Diphosphate-Ribose Polymerase (PARP) Inhibitor
Yes
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Previous Poly Adenosine Diphosphate-Ribose Polymerase (PARP) Inhibitor
No
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Number of days from the day the subject received the first dose of protocol therapy to the date of documented progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death (regardless of cause), assessed up to 3 yearsPFS was summarized using Kaplan-Meier analyses and compared between the two arms using the logrank test. Additionally, PFS was analyzed using a Cox Proportional Hazards Model, including the stratification factor, and will be used to estimate the hazard ratio of the gemcitabine hydrochloride (gemcitabine)/ataxia telangiectasia mutated and Rad3-related (ATR) kinase inhibitor M6620 (formerly VX-970) arm relative to the gemcitabine alone arm and the associated 90% confidence interval. Disease progression, per protocol, is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Progression Free Survival (PFS)
|
14.7 Weeks
Interval 9.7 to 36.7
|
22.9 Weeks
Interval 17.9 to 72.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsDefined as the percentage of subjects achieving a response rating of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) in the whole population. Per RECIST v1.1 definitions for target lesions and assessed by conventional CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR. ORR was summarized by counts (percentages) in each Arm.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Objective Response Rate (ORR)
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Number of days from the day the subject received the first dose of protocol therapy to the date of documented progressive disease by RECIST version 1.1 or death (regardless of cause), assessed at 6 monthsAssessed and compared PFS-6 between gemcitabine/VX-970 and gemcitabine alone arms
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Progression Free Survival at 6 Months (PFS-6)
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsCBR is defined as the percentage of subjects achieving a response rating of stable disease \>= 4 months, partial response (PR), or complete response (CR). Subject demographic and baseline characteristics will be summarized by mean, standard deviation, median, minimum, and maximum for continuous variables; and by counts and percentages for categorical variables. Summaries will be provided separately for each treatment group. Treatment group comparisons in CBR will be evaluated using logistic regression and expressed as odds ratios with associated 90% confidence intervals. In the event that rates are low, comparisons will be based on Fisher's exact test.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The rows in the data table below represent the patients within the specified platinum-free interval category who experienced an objective response.
Objective response rate by platinum-free status includes only informational summaries (counts of participants who met the categories outlined below) without formal statistical comparisons.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Objective Response Rate by Platinum Free Status
Patients who experienced an ORR with a platinum-free interval ≤3 months
|
1 Participants
|
1 Participants
|
|
Objective Response Rate by Platinum Free Status
Patients who experienced an ORR with a platinum-free interval 3-6 months
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: CA-125 serum samples were collected from participants in both Arms I and II at baseline, on Day 1 of each cycle, and at the end-of-study treatment visit, assessed up to 2 years.Determined and compared CA125 reduction by \> 50% between gemcitabine/VX-970 and gemcitabine alone arms.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Percentage of Patients With a Reduction in CA-125
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Number of weeks from the date of registration until date of death (regardless of cause), assessed up to 3 years.Assessed and compared OS between gemcitabine/VX-970 and gemcitabine alone arms.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Overall Survival (OS)
|
43.0 Weeks
Interval 34.4 to 67.9
|
59.4 Weeks
Interval 33.7 to 86.6
|
SECONDARY outcome
Timeframe: AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.Determined and compared the safety profile of gemcitabine/VX-970 and gemcitabine alone regimens.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Assessed for up to 3 years.Population: Duration of response was evaluated only for patients who showed a CR or PR. Subjects who had a best response of SD, progressive disease, or were removed from treatment before the first assessment of response were not evaluated for duration of response.
Duration of response was evaluated at the first instance of CR or PR through the earliest assessment of progressive disease, death, or the last follow-up where the subject had not yet progressed from her prior response. Informational summaries without formal statistical comparisons were produced.
Outcome measures
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=4 Participants
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=1 Participants
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
|---|---|---|
|
Duration of Response
Patient 1
|
10 Weeks
|
—
|
|
Duration of Response
Patient 2
|
6 Weeks
|
—
|
|
Duration of Response
Patient 3
|
18 Weeks
|
—
|
|
Duration of Response
Patient 4
|
27 Weeks
|
—
|
|
Duration of Response
Patient 5
|
—
|
7 Weeks
|
Adverse Events
Arm I (Gemcitabine Hydrochloride)
Serious events: 10 serious events
Other events: 36 other events
Deaths: 18 deaths
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
Serious events: 9 serious events
Other events: 34 other events
Deaths: 24 deaths
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620) After Crossover
Serious events: 3 serious events
Other events: 15 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 participants at risk
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620) After Crossover
n=15 participants at risk
Per protocol, participants could cross-over from "Arm I (Gemcitabine Hydrochloride)" to "Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)" if disease progression was experienced. This adverse event arm demonstrates the events which occurred during Arm II treatment for the 15 total participants who crossed over.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Vascular disorders
Capillary leak syndrome
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Fever
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Investigations
Platelet count decrease
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
11.8%
4/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Infections and infestations
Lung infection
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Chills
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Endocrine disorders
Addisonian crisis
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Neutrophil count decrease
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
13.3%
2/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
Other adverse events
| Measure |
Arm I (Gemcitabine Hydrochloride)
n=36 participants at risk
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)
n=34 participants at risk
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Berzosertib: Given IV
Gemcitabine: Given IV
Gemcitabine Hydrochloride: Given IV
|
Arm II (Gemcitabine, ATR Kinase Inhibitor M6620) After Crossover
n=15 participants at risk
Per protocol, participants could cross-over from "Arm I (Gemcitabine Hydrochloride)" to "Arm II (Gemcitabine, ATR Kinase Inhibitor M6620)" if disease progression was experienced. This adverse event arm demonstrates the events which occurred during Arm II treatment for the 15 total participants who crossed over.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
24/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
64.7%
22/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
46.7%
7/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Blood Bilirubin Decreased
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Decreased BUN
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Decreased Hematocrit
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Decreased MCHC
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Decreased RBC
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Increased Absolute Immature Granulocyte
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Increased MCV
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Increased RDW
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Increased Red Blood Cell Distribution
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
16.7%
6/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
13.3%
2/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
58.3%
21/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
67.6%
23/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
26.7%
4/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
13.9%
5/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
38.2%
13/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Blood and lymphatic system disorders
White Blood Cell Decreased
|
22.2%
8/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
23.5%
8/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
13.3%
2/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Cardiac disorders
Myocardial Infarction
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Endocrine disorders
Increased BUN
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Eye disorders
Eye pain
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
4/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
17.6%
6/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Decreased Appetite
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
6/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
23.5%
8/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
20.0%
3/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Mucositis Oral
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
17.6%
6/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
47.2%
17/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
55.9%
19/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
40.0%
6/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Small Intestinal Mucositis
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
7/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
32.4%
11/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
26.7%
4/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Chills
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
14.7%
5/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Edema Limbs
|
19.4%
7/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Fatigue
|
58.3%
21/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
64.7%
22/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
26.7%
4/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Fever
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
20.6%
7/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
13.3%
2/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Flu Like Symptoms
|
11.1%
4/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
11.8%
4/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Infusion Related Reaction
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Localized Edema
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Malaise
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Infections and infestations
Mucosal Infection
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Infections and infestations
Skin Infection
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
8.8%
3/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Investigations
Alanine Aminotransferase Increased
|
19.4%
7/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
29.4%
10/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
13.3%
2/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Investigations
Alkaline Phosphatase Increased
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
20.0%
3/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Investigations
Aspartate Aminotransferase Increased
|
22.2%
8/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
35.3%
12/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
13.3%
2/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Investigations
Cardiac Troponin T Increased
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Investigations
Creatinine Increased
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Investigations
Lipase Increased
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.9%
5/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
20.6%
7/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
20.0%
3/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
3/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
4/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramping
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
3/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
14.7%
5/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Restless Legs
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Nervous system disorders
Dysgeusia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Nervous system disorders
Headache
|
8.3%
3/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
23.5%
8/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Nervous system disorders
Unbalanced
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
8.8%
3/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
14.7%
5/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
13.3%
2/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
8.8%
3/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
14.7%
5/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Derm Other-left Wrist
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Itch
|
2.8%
1/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Nonfluid Filled Blisters On Thumbs
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
5.6%
2/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
5.9%
2/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
6.7%
1/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
13.9%
5/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
11.8%
4/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Red Painful Finger/thumbs
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Skin and subcutaneous tissue disorders
Red Painful Thumbs And Toes
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Vascular disorders
Flushing
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/36 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
2.9%
1/34 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
0.00%
0/15 • AE checks occurred on D1 and D8 of each cycle for up to 2 years and at the Final Treatment Visit. Patients who were removed from study treatment for unacceptable AEs were followed until resolution/stabilization of the AE up to 3 years, or until death.
Safety and adverse events were assessed on day 1 and day 8 of each cycle and were graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0.
|
Additional Information
Panagiotis Konstantinopoulos, MD, PhD
Dana-Farber Cancer Institute
Phone: 617-632-5269
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60