Trial Outcomes & Findings for Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer (NCT NCT00911820)
NCT ID: NCT00911820
Last Updated: 2022-11-08
Results Overview
7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. 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
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.
Results posted on
2022-11-08
Participant Flow
Patients were enrolled between July 2009 and April 2011.
Participant milestones
| Measure |
Arm A: PCA
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
|
Overall Study
Treated
|
44
|
41
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
45
|
43
|
Reasons for withdrawal
| Measure |
Arm A: PCA
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Overall Study
RECIST progression
|
12
|
8
|
|
Overall Study
Adverse Event
|
8
|
8
|
|
Overall Study
Clinical Progression
|
7
|
5
|
|
Overall Study
Physician Decision
|
5
|
9
|
|
Overall Study
Decline in Performance Status
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Pursue surgery
|
1
|
1
|
|
Overall Study
Pursue Radiation
|
1
|
0
|
|
Overall Study
Still on Therapy
|
2
|
2
|
|
Overall Study
Pathology Not Confirmed
|
1
|
0
|
|
Overall Study
Withdraw before Receive Treatment
|
0
|
2
|
Baseline Characteristics
Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Baseline characteristics by cohort
| Measure |
Arm A: PCA
n=44 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
61 years
n=107 Participants
|
60 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
ECOG Performance Status (PS)
ECOG PS 0/1
|
43 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
ECOG Performance Status (PS)
ECOG PS 2
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Tumor Location
Esophagus
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Tumor Location
GE Junction
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Tumor Location
Gastric
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.Population: The analysis dataset is comprised of all treated patients.
7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. 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 |
Arm A: PCA
n=44 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
7-month Progression-Free Survival
|
0.581 probability
Interval 0.421 to 0.712
|
0.582 probability
Interval 0.41 to 0.719
|
SECONDARY outcome
Timeframe: Patients in the study cohort were followed up to approximately 2.5 years as of this analysis.Population: The analysis dataset is comprised of all treated patients.
Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.
Outcome measures
| Measure |
Arm A: PCA
n=44 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Overall Survival
|
11.7 months
Interval 9.6 to 15.4
|
13.4 months
Interval 11.5 to 16.1
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis..Population: The analysis dataset is comprised of all treated patients.
Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; 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. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter 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. Stable disease is defined as any condition not meeting above criteria.
Outcome measures
| Measure |
Arm A: PCA
n=44 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Best Response
Partial Response
|
22 Participants
|
21 Participants
|
|
Best Response
Stable Disease
|
15 Participants
|
14 Participants
|
|
Best Response
Complete Response
|
3 Participants
|
0 Participants
|
|
Best Response
Progressive Disease
|
1 Participants
|
0 Participants
|
|
Best Response
Removed Before Restaging
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.Population: The analysis dataset is comprised of all treated patients.
Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
Arm A: PCA
n=44 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Overall Response (OR) Rate
|
.568 proportion of patients
Interval 0.41 to 0.717
|
.512 proportion of patients
Interval 0.351 to 0.671
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis.Population: The analysis dataset is comprised of all treated patients.
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease 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 |
Arm A: PCA
n=44 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 Participants
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Progression-Free Survival
|
7.9 months
Interval 6.1 to 10.1
|
8.4 months
Interval 6.2 to 9.7
|
Adverse Events
Arm A: PCA
Serious events: 32 serious events
Other events: 44 other events
Deaths: 0 deaths
Arm B: TPCA
Serious events: 36 serious events
Other events: 39 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A: PCA
n=44 participants at risk
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 participants at risk
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
9.8%
4/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Cardiac troponin I (cTnI)
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Cardiac-ischemia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Death - sudden death
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.6%
6/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
22.7%
10/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
31.7%
13/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophagus, hemorrhage
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Extremity-lower (gait/walking)
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
15.9%
7/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
22.0%
9/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
GI-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Head/headache
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hemorrhage-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Ileum, hemorrhage
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, esophagus
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr 3-4 neut, blood
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr3-4 neut, upper airway
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr3-4 neut, wound
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC appendix
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Leak, incl. anastomotic, small bowel
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Leukocytes
|
13.6%
6/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
26.8%
11/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphopenia
|
9.1%
4/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophils
|
25.0%
11/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
31.7%
13/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Perforation, colon
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelets
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Upper GI, hemorrhage NOS
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
4/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
Arm A: PCA
n=44 participants at risk
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally, on days 1 and 8 of each cycle, patients received cisplatin 30 mg/m2 IV over 30 minutes and then irinotecan 65 mg/m2 IV over 30 minutes of each 3-week cycle. Treatment could continue until disease progression or unacceptable toxicity.
|
Arm B: TPCA
n=41 participants at risk
Patients first received bevacizumab 10 mg/kg IV on day 1 of every cycle (cycle length=21 days) at approximately 0.5 mg/kg/minute. Additionally on days 1 and 8 of each cycle, patients received docetaxel 30 mg/m2 IV over 30 minutes followed by cisplatin 25 mg/m2 IV over 30 minutes and then irinotecan 50 mg/m2 IV over 30 minutes of each 3-week cycle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdomen, pain
|
38.6%
17/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
46.3%
19/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Agitation
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alkaline phosphatase
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Immune system disorders
Allergic reaction
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
17.1%
7/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Immune system disorders
Allergy-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
11/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
41.5%
17/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
ALT, SGPT
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
43.2%
19/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
68.3%
28/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Anus, hemorrhage
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Anxiety
|
20.5%
9/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
24.4%
10/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
AST, SGOT
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
15.9%
7/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
9.8%
4/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Bilirubin
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Buttock, pain
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Cardiac-other
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Cataract
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Chelitis
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Chest/thoracic pain NOS
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Coagulation-other
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Colon, hemorrhage
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Confusion
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
47.7%
21/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
43.9%
18/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Constitutional, other
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.7%
10/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
17.1%
7/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Creatinine
|
27.3%
12/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Cystitis
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Dehydration
|
34.1%
15/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
34.1%
14/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Depression
|
13.6%
6/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
70.5%
31/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
70.7%
29/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Dizziness
|
27.3%
12/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
24.4%
10/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Double vision
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
17.1%
7/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.9%
7/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
11/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.3%
12/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
22.0%
9/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema head and neck
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limb
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Endocrine disorders
Endocrine-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophagitis
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophagus, hemorrhage
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophagus, pain
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Extremity-lower (gait/walking)
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
79.5%
35/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
82.9%
34/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever w/o neutropenia
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Flatulence
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Flushing
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastritis
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
GI-other
|
13.6%
6/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
22.0%
9/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Head/headache
|
40.9%
18/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
29.3%
12/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Hearing-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hematoma
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
77.3%
34/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
68.3%
28/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hemorrhage-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hot flashes
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Hypercholesterolemia
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.5%
20/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
43.9%
18/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
22.7%
10/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
26.8%
11/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypertension
|
31.8%
14/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
17.1%
7/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.9%
7/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
31.7%
13/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.5%
9/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
36.6%
15/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.7%
10/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
24.4%
10/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
29.5%
13/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
39.0%
16/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
34.1%
15/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
34.1%
14/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, anal/perianl
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, catheter
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, dental-tooth
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, esophagus
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, external ear
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, foreign body
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, ungual
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection Gr0-2 neut, vagina
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ gr3-4 neut, paranasal
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC colon
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC lung
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC prostate
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC sinus
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC stomach
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC upper airway NOS
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC urinary tract NOS
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection w/ unk ANC vagina
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infection-other
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Injection site reaction
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
INR
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
18.2%
8/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
24.4%
10/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Irregular menses
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Kidney, hemorrhage
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Leak, incl. anastomotic, esophagitis
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Leak, incl. anastomotic, small bowel
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Leukocytes
|
52.3%
23/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
56.1%
23/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Libido
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Lip, pain
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Lung, hemorrhage
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphopenia
|
13.6%
6/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Memory impairment
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Mental status
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Metabolic/Laboratory-other
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Middle ear, pain
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis (symptom) larynx
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Muscular/skeletal hypoplasia
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
9.8%
4/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
9.8%
4/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
79.5%
35/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
75.6%
31/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neurologic-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy CN I smell
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy CN V jaw / face-sensory
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy CN VII face-motor / taste
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Neuropathy-sensory
|
18.2%
8/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
31.7%
13/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophils
|
43.2%
19/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
41.5%
17/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
22.0%
9/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
36.4%
16/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
41.5%
17/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Obstruction, small bowel NOS
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Ocular-other
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Oral cavity, hemorrhage
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Oral cavity, pain
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Oral gums, pain
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain-other
|
9.1%
4/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Palpitations
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Pelvic, pain
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Perforation, colon
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Perforation, stomach
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Pericarditis
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelets
|
52.3%
23/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
41.5%
17/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pleura, pain
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
PTT
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
13.6%
6/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
9.1%
4/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Rectum, pain
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Renal/GU-other
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Rigors/chills
|
9.1%
4/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Speech impairment
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Stenosis (incl anastomotic) esophagus
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Stomach, pain
|
18.2%
8/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Syncope
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Taste disturbance
|
18.2%
8/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
36.6%
15/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Tearing
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
7.3%
3/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Teeth
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
6.8%
3/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
12.2%
5/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Tremor
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Ulcer, cecum
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Ulcer, colon
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Ulcer, esophagus
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Ulcer, gastric
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Ulcer, stoma
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
9.8%
4/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
2/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Vascular-Other
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Vision-blurred
|
11.4%
5/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
2.4%
1/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Vision-flashing lights/floaters
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
9.1%
4/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
14.6%
6/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
22/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
51.2%
21/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight gain
|
2.3%
1/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
0.00%
0/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Weight loss
|
34.1%
15/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
31.7%
13/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
0.00%
0/44 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
4.9%
2/41 • Adverse events were assessed weeks 1 and 2 each cycle throughout treatment.Treatment duration was a median of 5 cycles (up to approximately 2 years) in this study cohort as of this analysis.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place