Trial Outcomes & Findings for Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer (NCT NCT00378703)
NCT ID: NCT00378703
Last Updated: 2018-11-14
Results Overview
Progression-free survival is defined as time from randomization to clinical evidence of disease progression or death from any cause without progression. Patients alive without progression were censored at the date of last disease assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
361 participants
Primary outcome timeframe
Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years
Results posted on
2018-11-14
Participant Flow
Participants were recruited from ECOG member institutions between September 14, 2007 and December 10, 2010 with a final accrual of 361 patients.
Participant milestones
| Measure |
Arm A (Bevacizumab)
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV
|
Arm B (Bevacizumab and Temsirolimus)
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV
|
Arm C (Bevacizumab and Sorafenib)
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV
|
Arm D (Sorafenib and Temsirolimus)
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
91
|
90
|
91
|
|
Overall Study
Treated
|
88
|
86
|
90
|
91
|
|
Overall Study
Eligible and Treated
|
84
|
80
|
83
|
84
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
89
|
91
|
90
|
91
|
Reasons for withdrawal
| Measure |
Arm A (Bevacizumab)
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV
|
Arm B (Bevacizumab and Temsirolimus)
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV
|
Arm C (Bevacizumab and Sorafenib)
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV
|
Arm D (Sorafenib and Temsirolimus)
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV
|
|---|---|---|---|---|
|
Overall Study
Disease progression
|
59
|
43
|
48
|
49
|
|
Overall Study
Adverse Event
|
11
|
17
|
20
|
18
|
|
Overall Study
Death
|
2
|
2
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
5
|
7
|
|
Overall Study
Physician Decision
|
1
|
4
|
1
|
0
|
|
Overall Study
Alternative therapy
|
4
|
2
|
0
|
0
|
|
Overall Study
Other complicated disease
|
0
|
2
|
2
|
0
|
|
Overall Study
Symptomatic deterioration
|
0
|
1
|
0
|
2
|
|
Overall Study
Surgery
|
1
|
0
|
0
|
1
|
|
Overall Study
Joint decision of physician and patient
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse events and progressive disease
|
0
|
0
|
0
|
1
|
|
Overall Study
Relocation
|
0
|
0
|
1
|
0
|
|
Overall Study
Ineligible
|
4
|
7
|
7
|
7
|
|
Overall Study
Never started treatment
|
1
|
4
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
2
|
3
|
Baseline Characteristics
Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Bevacizumab)
n=84 Participants
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
|
Arm B (Bevacizumab and Temsirolimus)
n=80 Participants
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
|
Arm C (Bevacizumab and Sorafenib)
n=83 Participants
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
|
Arm D (Sorafenib and Temsirolimus)
n=84 Participants
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
213 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
241 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
80 participants
n=7 Participants
|
83 participants
n=5 Participants
|
84 participants
n=4 Participants
|
331 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 yearsPopulation: Eligible, treated patients
Progression-free survival is defined as time from randomization to clinical evidence of disease progression or death from any cause without progression. Patients alive without progression were censored at the date of last disease assessment.
Outcome measures
| Measure |
Arm B (Bevacizumab and Temsirolimus)
n=80 Participants
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV
|
Arm C (Bevacizumab and Sorafenib)
n=83 Participants
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV
|
Arm D (Sorafenib and Temsirolimus)
n=84 Participants
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV
|
Arm A (Bevacizumab)
n=84 Participants
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
7.6 Months
Interval 6.7 to 9.2
|
9.2 Months
Interval 7.5 to 11.4
|
7.4 Months
Interval 5.6 to 7.9
|
7.5 Months
Interval 5.8 to 10.8
|
SECONDARY outcome
Timeframe: Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 yearsPopulation: Eligible, treated patients
Patients whose date of progression was after 6 months or who were disease-free at last follow-up beyond 6 months were considered to be stable at 6 months and all other patients were not.
Outcome measures
| Measure |
Arm B (Bevacizumab and Temsirolimus)
n=80 Participants
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV
|
Arm C (Bevacizumab and Sorafenib)
n=83 Participants
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV
|
Arm D (Sorafenib and Temsirolimus)
n=84 Participants
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV
|
Arm A (Bevacizumab)
n=84 Participants
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV
|
|---|---|---|---|---|
|
Proportion of Patients With Stable Disease at 6 Months
|
0.562 Proportion of patients
Interval 0.447 to 0.673
|
0.590 Proportion of patients
Interval 0.477 to 0.697
|
0.524 Proportion of patients
Interval 0.412 to 0.634
|
0.548 Proportion of patients
Interval 0.435 to 0.657
|
SECONDARY outcome
Timeframe: Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 yearsPopulation: Eligible, treated patients
Overall survival was defined as the time from randomization to death. Patients alive at last contact were censored on the date of last contact.
Outcome measures
| Measure |
Arm B (Bevacizumab and Temsirolimus)
n=80 Participants
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV
|
Arm C (Bevacizumab and Sorafenib)
n=83 Participants
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV
|
Arm D (Sorafenib and Temsirolimus)
n=84 Participants
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV
|
Arm A (Bevacizumab)
n=84 Participants
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV
|
|---|---|---|---|---|
|
Overall Survival
|
24.7 Months
Interval 21.4 to 35.3
|
27.5 Months
Interval 21.5 to 37.4
|
24.3 Months
Interval 19.7 to 34.7
|
28.6 Months
Interval 22.3 to 34.9
|
SECONDARY outcome
Timeframe: Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 yearsPopulation: Eligible, treated patients
Response was assessed using Solid Tumor Response Criteria (RECIST). Patients with complete responses or partial responses are considered having an objective response.
Outcome measures
| Measure |
Arm B (Bevacizumab and Temsirolimus)
n=80 Participants
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
temsirolimus: Given IV
bevacizumab: Given IV
|
Arm C (Bevacizumab and Sorafenib)
n=83 Participants
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
Sorafenib: Given PO
bevacizumab: Given IV
|
Arm D (Sorafenib and Temsirolimus)
n=84 Participants
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
Sorafenib: Given PO
temsirolimus: Given IV
|
Arm A (Bevacizumab)
n=84 Participants
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
bevacizumab: Given IV
|
|---|---|---|---|---|
|
Objective Response Rate
|
0.316 Proportion of patients
Interval 0.216 to 0.431
|
0.305 Proportion of patients
Interval 0.208 to 0.416
|
0.202 Proportion of patients
Interval 0.123 to 0.304
|
0.133 Proportion of patients
Interval 0.068 to 0.225
|
Adverse Events
Arm A (Bevacizumab)
Serious events: 39 serious events
Other events: 80 other events
Deaths: 0 deaths
Arm B (Bevacizumab and Temsirolimus)
Serious events: 66 serious events
Other events: 86 other events
Deaths: 0 deaths
Arm C (Bevacizumab and Sorafenib)
Serious events: 74 serious events
Other events: 89 other events
Deaths: 0 deaths
Arm D (Sorafenib and Temsirolimus)
Serious events: 76 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Bevacizumab)
n=88 participants at risk
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
|
Arm B (Bevacizumab and Temsirolimus)
n=86 participants at risk
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
|
Arm C (Bevacizumab and Sorafenib)
n=90 participants at risk
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
|
Arm D (Sorafenib and Temsirolimus)
n=91 participants at risk
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
|
|---|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.8%
8/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.0%
10/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.8%
8/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Sinus arrhythmia
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac-ischemia
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Cardiac troponin I (cTnI)
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
20.5%
18/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.4%
15/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
37.8%
34/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
7/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.1%
13/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
10/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.4%
14/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
7/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
20/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.0%
6/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
6/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.9%
9/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Necrosis, colon/cecum/appendix
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Obstruction, colon
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Perforation, colon
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ulcer, anus
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ulcer, gastric
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
GI-other
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
CNS, hemorrhage
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung, hemorrhage
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, abdomen
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, anal/perianl
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, bone
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, dental-tooth
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, kidney
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, rectum
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, salivary
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, wound
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC lung
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
ALT, SGPT
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Amylase
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
AST, SGOT
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Bilirubin
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Hypercholesterolemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.7%
4/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.5%
5/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Glomerular filtration rate
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
10.5%
9/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.6%
16/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lipase
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.1%
7/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
10/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.0%
30/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.5%
5/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Proteinuria
|
10.2%
9/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
22/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
10.0%
9/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.9%
8/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.7%
4/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.5%
5/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Seizure
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Cataract
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Keratitis
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
6/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Anus, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac/heart, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chest/thoracic pain NOS
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathic, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Oral cavity, pain
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Rectum, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.0%
6/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction, airway-bronchus
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Vital capacity
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.7%
4/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Vascular-Other (Specify)
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (Bevacizumab)
n=88 participants at risk
Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
|
Arm B (Bevacizumab and Temsirolimus)
n=86 participants at risk
Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
|
Arm C (Bevacizumab and Sorafenib)
n=90 participants at risk
Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
|
Arm D (Sorafenib and Temsirolimus)
n=91 participants at risk
Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Bicarbonate
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Bilirubin
|
3.4%
3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
6/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.6%
6/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
18.6%
16/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
13.3%
12/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.0%
20/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Hypercholesterolemia
|
12.5%
11/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
45.3%
39/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.8%
16/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
37.4%
34/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine
|
28.4%
25/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
43/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
41.1%
37/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
38.5%
35/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Glomerular filtration rate
|
3.4%
3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
6/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.6%
12/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
54.7%
47/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
30/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
54.9%
50/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.2%
9/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.6%
10/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
10.0%
9/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.5%
5/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
34.1%
30/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
75.6%
65/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
41.1%
37/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
82.4%
75/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes
|
4.5%
4/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
37.2%
32/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
13.3%
12/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.5%
46/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
8.0%
7/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
24.4%
21/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.8%
16/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
30.8%
28/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
24.4%
21/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
24.2%
22/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets
|
14.8%
13/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
43/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
23.3%
21/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
57.1%
52/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
33.0%
29/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
45.3%
39/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
46.7%
42/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
37.4%
34/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
54.5%
48/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
76.7%
66/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
71.1%
64/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
82.4%
75/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.8%
11/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
6/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
14.3%
13/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.1%
7/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.8%
7/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.0%
10/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
14.0%
12/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.8%
7/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.8%
8/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
8.0%
7/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.6%
28/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
34.4%
31/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
40.7%
37/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
11/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
24.4%
21/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
30/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.0%
30/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Flushing
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.6%
5/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.6%
10/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
14.4%
13/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.4%
14/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.1%
13/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
14.4%
13/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.6%
16/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.8%
6/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
31.4%
27/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
10.0%
9/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
31.9%
29/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.4%
3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
40.7%
35/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.8%
16/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
45.1%
41/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
3.4%
3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
41.9%
36/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.6%
14/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
42.9%
39/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
3.4%
3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.4%
15/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
47.8%
43/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
28.6%
26/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
13.6%
12/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
53.5%
46/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
45.6%
41/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
52.7%
48/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
15.9%
14/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
27.9%
24/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
23/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
26.4%
24/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
17.0%
15/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
46.5%
40/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
45/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
71.4%
65/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.3%
2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.6%
6/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
7/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.1%
7/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
21.1%
19/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
7/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
22/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
20/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
14.3%
13/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
46.5%
40/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
36.7%
33/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
26.4%
24/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
19.3%
17/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
43.0%
37/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
42.2%
38/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
54.9%
50/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.7%
29/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
26.7%
24/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
38.5%
35/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
7/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
20.9%
18/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
23/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
26.4%
24/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
20.5%
18/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
41.9%
36/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.2%
29/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
24.2%
22/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.1%
7/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema head and neck
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.6%
6/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.4%
15/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.2%
11/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
19.8%
18/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
26.7%
23/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
18.9%
17/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
18.7%
17/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase
|
10.2%
9/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.1%
19/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
21.1%
19/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
37.4%
34/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
ALT, SGPT
|
12.5%
11/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
26.7%
23/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.2%
11/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
39.6%
36/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Amylase
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.3%
8/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.2%
11/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.9%
9/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
AST, SGOT
|
13.6%
12/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
30.2%
26/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
23/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
42.9%
39/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lipase
|
8.0%
7/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.1%
13/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
23/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.4%
14/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.2%
1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.5%
5/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.8%
6/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
24.4%
21/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.2%
29/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
58.2%
53/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.0%
6/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
10/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.5%
5/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.7%
5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.3%
14/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.8%
7/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
18.7%
17/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Proteinuria
|
28.4%
25/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
46.5%
40/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
45/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
2.2%
2/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
7/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.3%
8/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
21.1%
19/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.0%
20/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
19.3%
17/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
45.3%
39/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.2%
29/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
46.2%
42/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Metabolic/Laboratory-other
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.6%
10/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
10/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.8%
8/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
1.1%
1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.8%
7/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
4.5%
4/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
15.1%
13/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.7%
6/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.0%
10/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.6%
10/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
20/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.1%
11/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Tearing
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
4.5%
4/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.1%
7/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.7%
15/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
26.4%
24/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
4.5%
4/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.8%
11/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.8%
8/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chest/thoracic pain NOS
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
10.5%
9/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.3%
3/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.5%
5/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.5%
3/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
8.9%
8/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
7/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
14.8%
13/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.6%
28/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
23/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
24.2%
22/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
11.4%
10/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
20.9%
18/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.8%
16/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.5%
15/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
2.3%
2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.8%
5/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
10.0%
9/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.7%
7/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Oral cavity, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
7.0%
6/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.7%
4/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
5.6%
5/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
1.1%
1/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
7/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.6%
22/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
10.0%
9/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
17.6%
16/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
8/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
34.9%
30/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
14.4%
13/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
23.1%
21/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.3%
8/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
4.4%
4/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
10.2%
9/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
14.0%
12/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
30/90 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.1%
11/91 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60