Trial Outcomes & Findings for RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer (NCT NCT01058655)
NCT ID: NCT01058655
Last Updated: 2017-04-13
Results Overview
PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Disease was assessed radiographically to document clinical progression every 2 cycles on treatment. Participants were followed for up to 16 months since study entry.
Results posted on
2017-04-13
Participant Flow
Patients enrolled from February 2010 through June 2011.
Participant milestones
| Measure |
Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase II: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|---|
|
Overall Study
Evaluable
|
3
|
3
|
6
|
40
|
|
Overall Study
STARTED
|
3
|
3
|
8
|
42
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
8
|
42
|
Reasons for withdrawal
| Measure |
Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase II: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
4
|
|
Overall Study
Prolonged Treatment Delay
|
0
|
0
|
0
|
2
|
|
Overall Study
Symptomatic Deterioration
|
0
|
0
|
0
|
1
|
|
Overall Study
Clinical Progression (non-RECIST)
|
1
|
0
|
0
|
7
|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
|
Overall Study
Disease Progression
|
1
|
2
|
4
|
24
|
|
Overall Study
Other
|
0
|
0
|
0
|
4
|
Baseline Characteristics
RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg
n=3 Participants
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
n=3 Participants
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
n=8 Participants
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase II: Everolimus 10 mg + Tivozanib 1 mg
n=42 Participants
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
47 years
n=7 Participants
|
63 years
n=5 Participants
|
56 years
n=4 Participants
|
59 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.Population: All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.
The everolimus MTD in combination with tivozanib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.
Outcome measures
| Measure |
Phase I: Evaluable
n=12 Participants
All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|
|
Everolimus Maximum Tolerated Dose (MTD) [Phase I]
|
10 mg daily for 4 weeks of a 4 week cycle
|
—
|
—
|
PRIMARY outcome
Timeframe: Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.Population: All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.
The tivozanib MTD in combination with everolimus is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.
Outcome measures
| Measure |
Phase I: Evaluable
n=12 Participants
All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|
|
Tivozanib Maximum Tolerated Dose (MTD) [Phase I]
|
1.0 mg daily for 3 weeks of a 4 week cycle
|
—
|
—
|
PRIMARY outcome
Timeframe: Patients were assessed continuously for toxicity while on study. The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.Population: All PI patients who received at least one dose of the study drug were evaluable for DLT. The 2 DLTs experienced by participants in dose level cohort 3 were grade 3 fatigue and dehydration.
A DLT was defined as a treatment-related (attribution possible, probable, definite) adverse event that meets any of the following criteria: Grade 3 (G3) or higher non-hematologic toxicity (excluding, nausea, vomiting, diarrhea, alopecia, hypertension, hypercholesterolemia, or hypertriglyceridemia); G3 diarrhea, nausea or vomiting lasting \> 48 hours or leading to hospitalization, despite aggressive anti-diarrheal or anti-emetic medications; G4 diarrhea, despite aggressive anti-diarrheal medications; G4 vomiting, despite aggressive anti-emetic medications; G3 hypertension, for which blood pressure cannot be reduced to \<150/100 with anti-hypertensive therapies; G4 hypertension or severe hypertension, as defined by systolic blood pressure \>180 mmHg or diastolic blood pressure \> 110 mmHg; G4 hypercholesterolemia or hypertriglyceridemia lasting \> 7 days, despite appropriate use of anti-hyperlipidemic medications; G4 hematologic toxicity lasting for \>5 days, including leukopenia, neutropen
Outcome measures
| Measure |
Phase I: Evaluable
n=3 Participants
All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
n=3 Participants
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
n=6 Participants
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|
|
Dose Limiting Toxicity (DLT) [Phase I]
|
0 Participants with DLT
|
0 Participants with DLT
|
2 Participants with DLT
|
PRIMARY outcome
Timeframe: Disease was assessed radiographically to document clinical progression every 2 cycles on treatment. Participants were followed for up to 16 months since study entry.Population: The analysis dataset is comprised of all evaluable phase II patients.
PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Phase I: Evaluable
n=40 Participants
All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|
|
Progression-Free Survival (PFS) [Phase II]
|
3.0 months
Interval 1.9 to 3.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease was assessed every 2 cycles on treatment. Median treatment duration on this study cohort was 2 months (range 1-16).Population: The analysis dataset is comprised of all evaluable phase II patients.
Disease Control Rate is defined as the percentage of patients who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Phase I: Evaluable
n=40 Participants
All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|
|
Disease Control Rate (DCR) [Phase II]
|
50 percentage of participants
Interval 34.0 to 66.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Long-term follow-up for survival was not specified per protocol. Participants were followed for up to 20 months on this study.Population: The analysis dataset is comprised of all evaluable phase II patients.
OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
Phase I: Evaluable
n=40 Participants
All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|
|
Overall Survival (OS) [Phase II]
|
5.6 months
Interval 4.4 to 10.6
|
—
|
—
|
Adverse Events
Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II: Everolimus 10 mg + Tivozanib 1 mg
Serious events: 30 serious events
Other events: 32 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg
n=3 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
n=3 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
n=8 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase II: Everolimus 10 mg + Tivozanib 1 mg
n=42 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|---|
|
Investigations
ALT- SGPT
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
AST- SGOT
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Abdomen- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
25.0%
2/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Back- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Bilirubin
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Breast- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Chest wall- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Chest/thoracic pain NOS
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Creatinine
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Death - disease progression NOS
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
14.3%
6/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
7.1%
3/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
26.2%
11/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection w/ unk ANC kidney
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Injury, poisoning and procedural complications
Intra-op injury
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Injury, poisoning and procedural complications
Intra-op injury Colon
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Injury, poisoning and procedural complications
Intra-op injury Spinal cord
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Lymphopenia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Obstruction- small bowel NOS
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Platelets
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
23.8%
10/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Rectum- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Eye disorders
Retinal detachment
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Stenosis (incl anastomotic) biliary tree
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Varices (esophageal)- hemorrhage
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
Other adverse events
| Measure |
Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg
n=3 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg
n=3 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg
n=8 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
Phase II: Everolimus 10 mg + Tivozanib 1 mg
n=42 participants at risk
Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
47.6%
20/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
ALT- SGPT
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
25.0%
2/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
16.7%
7/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
AST- SGOT
|
100.0%
3/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
40.5%
17/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Abdomen- pain
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
35.7%
15/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
38.1%
16/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
26.2%
11/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Cardiac disorders
Atrial tachycardia/PAT
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Back- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
14.3%
6/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Bilirubin
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Bone- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm- wheezing
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Chest wall- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Nervous system disorders
CNS- hemorrhage
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
14.3%
6/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Creatinine
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dental/teeth/peridontal- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
66.7%
2/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
50.0%
4/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
31.0%
13/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Distention/bloating- abdominal
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
14.3%
6/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Edema head and neck
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Edema limb
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Ear and labyrinth disorders
External ear- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Extremity-lower (gait/walking)
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
37.5%
3/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
40.5%
17/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
7.1%
3/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Nervous system disorders
Head/headache
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
14.3%
6/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
31.0%
13/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
42.9%
18/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Vascular disorders
Hypertension
|
100.0%
3/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
37.5%
3/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
40.5%
17/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
35.7%
15/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
7.1%
3/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
45.2%
19/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
38.1%
16/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
26.2%
11/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
25.0%
2/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
14/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
2/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
37.5%
3/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
16.7%
7/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut- bronchus
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut- dental-tooth
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut- oral cavity
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut- sinus
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection Gr0-2 neut- urinary tract
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
7.1%
3/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection w/ unk ANC bronchus
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Infections and infestations
Infection w/ unk ANC vagina
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Joint- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Leukocytes
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Lip- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Blood and lymphatic system disorders
Lymph node- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Lymphopenia
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Nervous system disorders
Mental status
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
66.7%
2/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
25.0%
2/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
16.7%
7/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
21.4%
9/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Muscle- pain
|
66.7%
2/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
37.5%
3/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
14/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Neck- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Neutrophils
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
21.4%
9/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Nose- hemorrhage
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Pelvic- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Platelets
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
50.0%
4/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
38.1%
16/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
16.7%
7/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
7.1%
3/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
16.7%
7/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Rectum- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
General disorders
Rigors/chills
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Stenosis (incl anastomotic) duodenum
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Stomach- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
4.8%
2/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Renal and urinary disorders
Urethra- pain
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
7.1%
3/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
2.4%
1/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
0.00%
0/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
12.5%
1/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
11.9%
5/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
|
Investigations
Weight loss
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
33.3%
1/3 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
25.0%
2/8 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
9.5%
4/42 • Adverse events (AEs) were assessed continuously throughout treatment. Treatment duration was a median of 2 months (range 1-16 months) in this study cohort.
AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv3.
|
Additional Information
Brian M. Wolpin
Dana-Farber Cancer Institute
Phone: 617.632.6942
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place