Trial Outcomes & Findings for Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma (NCT NCT00433381)
NCT ID: NCT00433381
Last Updated: 2018-09-17
Results Overview
Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
From randomization to six months.
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
Arm I (Bevacizumab and Temozolomide)
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
60
|
|
Overall Study
COMPLETED
|
60
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Arm I (Bevacizumab and Temozolomide)
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Overall Study
Ineligible / no protocol treatment
|
3
|
3
|
Baseline Characteristics
Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma
Baseline characteristics by cohort
| Measure |
Arm I (Bevacizumab and Temozolomide)
n=60 Participants
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=57 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
n=39 Participants
|
55 years
n=41 Participants
|
56 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=39 Participants
|
34 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From randomization to six months.Population: Eligible patients with six-month data.
Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=57 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm
|
22 Participants
|
—
|
PRIMARY outcome
Timeframe: From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor).Population: The first 29 eligible patients who received protocol treatment were to be evaluated for treatment tolerability.
This endpoint determines tolerability of this treatment arm. If tolerable, then the secondary endpoint of treatment efficacy for this arm occurs. Percentage is calculated by taking the number of patients who did not stop bevacizumab and temozolomide treatment due to medical complications in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who did not begin treatment.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=29 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Count/Percentage of Patients Discontinuing Treatment Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm)
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 and 8 weeks posttreatment, and every 2 months until 96wksPopulation: A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI. Of 123 main subjects, a subset of 20 consented to the MRS substudy, of whom 13 had analyzable MRS datasets. this subset is independent of Study Arm.
Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 6-month progression-free survival (PFS-6) over all study participants. Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to progression, evaluated at 96wks, is the determinate of PFS at 6months (PFS-6). Subjects will not be analyzed by arm.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=13 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6)
PFS <= 6mo
|
4 Participants
|
—
|
|
Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6)
PFS > 6mo
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 and 8 weeks posttreatment, and every 2 months until 96wksPopulation: A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI. Subjects participated in the MR substudies regardless of therapeutic intervention
Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 12-month overall survival (OS). Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to death, evaluated at 96wks, is the determinate of OS at 12 months. Subjects will not be analyzed by arm.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=13 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Number of Participants With Predicted Overall Survival (OS) at 12 Months
OS <=12mo
|
6 Participants
|
—
|
|
Number of Participants With Predicted Overall Survival (OS) at 12 Months
OS>12 mo
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: From randomization to six months.Population: Eligible patients with six-month data.
Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=59 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Temozolomide Arm
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: From randomization to death or last follow-up. Patients were followed up to 62.9 months.Population: Eligible patients with measurable disease at baseline
Tumor size measured in millimeters and is the largest crosssectional area using perpendicular measurements of contrast enhancing abnormality. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off corticosteroids, and neurologically stable or improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive MRI scans at least 1 month apart, corticosteroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Stable disease (SD): Does not qualify for CR, PR, or PD.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=58 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=54 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)
Complete Response
|
2 Participants
|
2 Participants
|
|
Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)
Partial Response
|
9 Participants
|
13 Participants
|
|
Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)
Stable Disease
|
32 Participants
|
26 Participants
|
|
Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)
Progressive Disease
|
10 Participants
|
12 Participants
|
|
Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression)
Indeterminate
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatmentPopulation: Of the 123 subject accrued to ACRIN 6677, 103 were analyzable for this aim. Reasons for exclusions were as follows: 11 subjects only had baseline imaging, 4 were ineligible, 1 was lost to followup, and 4 had incomplete/uninterpretable images.
Local and central interpretations of the standard MRI were assessed for progression and survival at all available imaging (baseline visit, week 2, and after every 2 cycles of treatment, and at termination of treatment). Patients who suffer clinical progression without radiographic confirmation of progression were considered to have progressive disease in determination of PFS-6. Subjects participated in the MR substudies regardless of therapeutic intervention
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=103 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Agreement Between Local Interpretation and Central Interpretation of Standard MRI
Local Read · PFS <= 6mo
|
62 Participants
|
—
|
|
Agreement Between Local Interpretation and Central Interpretation of Standard MRI
Local Read · PFS >= 6mo
|
41 Participants
|
—
|
|
Agreement Between Local Interpretation and Central Interpretation of Standard MRI
Central Read · PFS <= 6mo
|
55 Participants
|
—
|
|
Agreement Between Local Interpretation and Central Interpretation of Standard MRI
Central Read · PFS >= 6mo
|
48 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatmentPopulation: Standard of care MRI occurred at baseline, after every 2 cycles of treatment (every 8 weeks), and after completion/termination of treatment. Subjects participated in the MR substudies regardless of therapeutic intervention
Local reads were treated as the test and central reads were treated as the reference standard. Thus, a participant meeting the definition of progression on any standard MRI central interpretation (baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment) was considered positive for PFS-6. Therefore, a true positive is defined as a positive local interpretation for a subject with a positive central read.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=103 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard
Local Read (Test) · PFS-6 Negative
|
62 Participants
|
—
|
|
Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard
Local Read (Test) · PFS-6 Positive
|
41 Participants
|
—
|
|
Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard
Central Read (Reference) · PFS-6 Negative
|
48 Participants
|
—
|
|
Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard
Central Read (Reference) · PFS-6 Positive
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeks following initiation of protocol treatment (T1) and at 8 weeks following chemotherapy with bevacizumab (T2)Population: This Aim was removed from the approved protocol aims. Data were not collected.
Aim not included in final (February 10, 2009) protocol (removed from section 2).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks following initiation of protocol treatment (T1)Population: This Aim was removed from the approved protocol aims. Data were not collected.
Aim not included in final (February 10, 2009) protocol (removed from section 2)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks following initiation of protocol treatment (T1)Population: This Aim was removed from the approved protocol aims. Data were not collected.
Aim not included in final (February 10, 2009) protocol (removed from section 2)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 2 WeeksPopulation: Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention
To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 2 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 2 are the prognostic indicators.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=13 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Change in Perfusion MRI Markers at Week 2 as Predictors of 12mo Overall Survival (OS)
nRCBV (%change @ week2)
|
0.85 Area Under the Curve (AUC)
Interval 0.624 to 1.0
|
—
|
|
Change in Perfusion MRI Markers at Week 2 as Predictors of 12mo Overall Survival (OS)
sRCBV (%change @ week2)
|
0.825 Area Under the Curve (AUC)
Interval 0.577 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention
To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 8 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 8 are the prognostic indicators.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=17 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Change in Perfusion MRI Markers at Week 8 as Predictors of 12mo Overall Survival (OS)
nRCBV (%change @ week8)
|
0.470 Area Under the Curve (AUC)
Interval 0.171 to 0.768
|
—
|
|
Change in Perfusion MRI Markers at Week 8 as Predictors of 12mo Overall Survival (OS)
sRCBV (%change @ week8)
|
0.561 Area Under the Curve (AUC)
Interval 0.277 to 0.844
|
—
|
SECONDARY outcome
Timeframe: Baseline and 16 WeeksPopulation: Analyzable participants are defined as those participants with DSC data supplied for the baseline scan and at least one scan post-baseline. Subjects participated in the MR substudies regardless of therapeutic intervention
To assess the potential role of perfusion MRI as a prognostic indicator for 12-month OS based on the change in MRI markers evaluated before treatment and 16 weeks following initiation of protocol treatment. Percent change in mean tumor relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast (DSC) MRI normalized to white matter (nRCBV) and standardized rCBV (sRCBV) between baseline and week 16 are the prognostic indicators.
Outcome measures
| Measure |
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=13 Participants
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
|
|---|---|---|
|
Change in Perfusion MRI Markers at Week 16 as Predictors of 12mo Overall Survival (OS)
nRCBV (%change @ week16)
|
0.762 Area Under the Curve (AUC)
Interval 0.435 to 1.0
|
—
|
|
Change in Perfusion MRI Markers at Week 16 as Predictors of 12mo Overall Survival (OS)
sRCBV (%change @ week16)
|
0.905 Area Under the Curve (AUC)
Interval 0.736 to 1.0
|
—
|
Adverse Events
Arm I (Bevacizumab and Temozolomide)
Serious events: 37 serious events
Other events: 55 other events
Deaths: 0 deaths
Arm II (Bevacizumab and Irinotecan Hydrochloride)
Serious events: 37 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Bevacizumab and Temozolomide)
n=60 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=57 participants at risk
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients.
|
|---|---|---|
|
Blood and lymphatic system disorders
Edema: limb:
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Epistaxis
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemorrhage, GI: Upper GI NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding - Other:
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemorrhagic stroke
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Intra-abdominal haemorrhage NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Neutrophil count
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
11.7%
7/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Rectal hemorrhage
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Urinary bladder hemorrhage
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Urogenital hemorrhage
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Cardiac General - Other:
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Hypotension NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Troponin I increased
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Auditory/ear - Other:
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Diplopia
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Anorexia
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colonic perforation
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal - Other:
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chest pain
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Death NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Disease progression NOS
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Multi-organ failure
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Rhinitis allergic NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Anal infection NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Ano-rectal infection NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Encephalitis NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection - Other:
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bladder (urinary)
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Colon
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Foreign body (e.g., graft, implant, pro
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Skin (cellulitis)
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Catheter-related
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Colon
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Larynx
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with unknown ANC: Upper airway NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Penile infection NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Respiratory tract infection NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Skin infection
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Blood alkaline phosphatase increased
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Metabolic/laboratory - Other:
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Proteinuria
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Fracture NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - Other:
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Agitation
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Anxiety
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Apnoea
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cerebrospinal fluid leak
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disorder
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Confusional state
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Convulsions NOS
|
15.0%
9/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Depression
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Encephalopathy
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Hyperreflexia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Mental status changes
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Speech disorder
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other:
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - Other:
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail disorder NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thrombosis
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Vascular access NOS complication
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Arm I (Bevacizumab and Temozolomide)
n=60 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60.
|
Arm II (Bevacizumab and Irinotecan Hydrochloride)
n=57 participants at risk
Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients.
|
|---|---|---|
|
Blood and lymphatic system disorders
Edema: limb:
|
26.7%
16/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Epistaxis
|
23.3%
14/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
43.3%
26/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
40.4%
23/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding - Other:
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemorrhagic stroke
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
36.7%
22/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
36.8%
21/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Lower gastrointestinal hemorrhage
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
48.3%
29/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
52.6%
30/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Neutrophil count
|
15.0%
9/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.6%
18/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
50.0%
30/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.1%
20/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Hypertension NOS
|
16.7%
10/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Hypotension NOS
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Endocrine disorders
Cushingoid
|
20.0%
12/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Ocular/visual - Other:
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Vision blurred
|
13.3%
8/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Anorexia
|
21.7%
13/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
21.7%
13/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
26.3%
15/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dehydration
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
18.3%
11/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
68.4%
39/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysgeusia
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Faecal incontinence
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastritis NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal - Other:
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
31.7%
19/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
52.6%
30/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Oral pain
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Stomatitis
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
23.3%
14/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
29.8%
17/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
65.0%
39/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
68.4%
39/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain - Other:
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pyrexia
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Rigors
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Syndromes - Other:
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Rhinitis allergic NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Bronchitis NOS
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Respiratory tract infection NOS
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Sinusitis NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection NOS
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Prothrombin time prolonged
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
11.7%
7/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
35.0%
21/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.6%
18/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
30.0%
18/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Blood alkaline phosphatase increased
|
15.0%
9/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.8%
9/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Blood amylase increased
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Blood bilirubin increased
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Blood creatinine increased
|
20.0%
12/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Gamma-glutamyltransferase increased
|
13.3%
8/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
56.7%
34/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.1%
24/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
20/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
19/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
15/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
36.8%
21/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycemia NOS
|
13.3%
8/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
10/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.7%
1/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
10/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.1%
16/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Lipase increased
|
30.0%
18/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Metabolic/laboratory - Other:
|
16.7%
10/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Proteinuria
|
16.7%
10/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Gait abnormal NOS
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.1%
12/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
|
13.3%
8/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-upper
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Right-sided
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Agitation
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Anxiety
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
11.7%
7/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.0%
8/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disorder
|
15.0%
9/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Confusional state
|
21.7%
13/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Convulsions NOS
|
21.7%
13/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Depressed level of consciousness
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Depression
|
3.3%
2/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
13.3%
8/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
31.7%
19/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.1%
24/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Hyperreflexia
|
21.7%
13/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
30.0%
18/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.3%
11/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Mental status changes
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Neurology - Other:
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Optic nerve disorder NOS
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
10/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Personality change
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Speech disorder
|
26.7%
16/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
24.6%
14/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Tremor
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
11.7%
7/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal/genitourinary - Other:
|
0.00%
0/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
9/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.5%
10/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.3%
7/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis NOS
|
11.7%
7/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other:
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
6/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Acne NOS
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.3%
3/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.8%
5/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
5/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.0%
4/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
13.3%
8/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
6/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
2/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Sweating increased
|
5.0%
3/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thrombosis
|
6.7%
4/60
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.8%
1/57
Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60