Trial Outcomes & Findings for Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT00723255)
NCT ID: NCT00723255
Last Updated: 2019-07-23
Results Overview
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
Results posted on
2019-07-23
Participant Flow
The study was activated on 9/8/2008 and closed to accrual on 3/22/2010 (and was suspended from 1/19/2009 to 12/7/2009).
Participant milestones
| Measure |
Bevacizumab Plus Temsirolimus
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Bevacizumab Plus Temsirolimus
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Ineligible: Inadequate pathology
|
1
|
|
Overall Study
Ineligible: Second primary
|
1
|
|
Overall Study
Ineligible: Wrong Primary
|
2
|
Baseline Characteristics
Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab Plus Temsirolimus
n=49 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Customized
20-29 years
|
0 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
1 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
11 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
21 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
11 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive diseasePopulation: Eligible and Treated Patients
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=49 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Tumor Response
|
24.5 percentage of participants
Interval 14.8 to 36.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every other cycle for 6 monthsPopulation: Eligible and Treated Patients
Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=49 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival at 6 Months
|
46.9 percentage of participants
Interval 34.6 to 59.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every cycle and 30 days after the last treatment, an average of 5 years.Population: Eligible and evaluable patients
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=49 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=49 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=49 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=49 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=49 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
n=49 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Leukopenia
|
20 Participants
|
13 Participants
|
15 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Thrombocytopenia
|
24 Participants
|
18 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Neutropenia
|
28 Participants
|
7 Participants
|
9 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Anemia
|
14 Participants
|
17 Participants
|
14 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Other hematologic
|
46 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Allergy/immunology
|
47 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Cardiac
|
33 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Coagulation
|
48 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Constitutional
|
12 Participants
|
9 Participants
|
18 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Dermatologic
|
18 Participants
|
13 Participants
|
16 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Endocrine
|
48 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Gastrointestinal
|
5 Participants
|
11 Participants
|
15 Participants
|
17 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Genitourinary/renal
|
44 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Hemorrhage
|
25 Participants
|
22 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Infection
|
34 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Lymphatics
|
40 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Metabolic
|
9 Participants
|
11 Participants
|
12 Participants
|
14 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Musculoskeletal
|
43 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Neurosensory
|
43 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Other neurological
|
41 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Ocular/visual
|
45 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Pain
|
18 Participants
|
12 Participants
|
10 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Pulmonary
|
26 Participants
|
14 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Sexual/reproductive
|
48 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Vascular
|
47 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Death, not CTC coded
|
48 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.Population: Eligible and Treated Patients
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=49 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival
|
5.6 Months
Interval 4.0 to 7.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From entry into the study to death or the date of last contact, up to 5 yearsPopulation: Eligible and Treated Patients
The observed length of life from entry into the study to death or the date of last contact.
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=49 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
16.9 Months
Interval 10.7 to 21.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive diseaseComplete and Partial Tumor Response by RECIST 1.0
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=29 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=20 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Complete and Partial Tumor Response by RECIST 1.0 by Performance Status
|
24 percentage of participants
Interval 10.0 to 44.0
|
25 percentage of participants
Interval 9.0 to 49.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle for 6 monthsPercentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=29 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=20 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival at 6 Months by Performance Status
|
48 percentage of participants
Interval 29.0 to 67.0
|
45 percentage of participants
Interval 23.0 to 68.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive diseaseComplete and Partial Tumor Response by RECIST 1.0
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=34 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=15 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type
|
21 percentage of participants
Interval 9.0 to 38.0
|
33 percentage of participants
Interval 12.0 to 62.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle for 6 monthsPercentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=34 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=15 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival at 6 Months by Histologic Type
|
44 percentage of participants
Interval 27.0 to 62.0
|
53 percentage of participants
Interval 27.0 to 79.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive diseaseComplete and Partial Tumor Response by RECIST 1.0
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=20 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=15 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade
|
30 percentage of participants
Interval 12.0 to 54.0
|
18 percentage of participants
Interval 5.0 to 40.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle for 6 monthsPercentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Bevacizumab Plus Temsirolimus
n=20 Participants
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 3.0)
n=15 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival at 6 Months by Tumor Grade
|
60 percentage of participants
Interval 36.0 to 81.0
|
32 percentage of participants
Interval 14.0 to 55.0
|
—
|
—
|
—
|
—
|
Adverse Events
Bevacizumab Plus Temsirolimus
Serious events: 31 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab Plus Temsirolimus
n=49 participants at risk
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Cardiac disorders
Hypertension
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Inr
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Fever
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Death No Ctcae Term - Sudden Death
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Anorexia
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Constipation
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Proteinuria
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Neck
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Rectum
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Abdominal Pain Nos
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Renal Failure
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
Other adverse events
| Measure |
Bevacizumab Plus Temsirolimus
n=49 participants at risk
Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Immune system disorders
Rhinitis
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Blood and lymphatic system disorders
Neutrophils
|
46.9%
23/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Blood and lymphatic system disorders
Platelets
|
55.1%
27/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Blood and lymphatic system disorders
Leukocytes
|
59.2%
29/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
79.6%
39/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Palpitations
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Vasovagal Episode
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Hypertension
|
30.6%
15/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Restrictive Cardiomyopathy
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Cardiac General - Other
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Pericardial Effusion
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Cardiac disorders
Hypotension
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Inr
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Ptt
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Constitutional Symptoms - Other
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Fever
|
14.3%
7/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Weight Loss
|
32.7%
16/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Rigors/Chills
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Fatigue
|
77.6%
38/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Insomnia
|
10.2%
5/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
20.4%
10/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
24.5%
12/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.2%
5/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
49.0%
24/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.4%
10/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Burn
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Endocrine disorders
Hot Flashes
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Proctitis
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Ulcer,gi - Stoma
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Heartburn
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Pharynx
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Dysphagia
|
12.2%
6/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Distention
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Taste Alteration
|
20.4%
10/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Incontinence, Anal
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
32.7%
16/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Stomach
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
34.7%
17/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Anus
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Vomiting
|
40.8%
20/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Anorexia
|
42.9%
21/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Dehydration
|
12.2%
6/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Constipation
|
40.8%
20/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Nausea
|
59.2%
29/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Gastrointestinal disorders
Diarrhea
|
59.2%
29/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
14.3%
7/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
46.9%
23/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hematoma
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Hemorrhage, Gi - Colon
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Nose
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
14.3%
7/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails)
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Infection - Other
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf Unknown Anc: External Ear
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
22.4%
11/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Ast
|
28.6%
14/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Gfr
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
57.1%
28/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Proteinuria
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Creatinine
|
20.4%
10/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.4%
10/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Alt
|
26.5%
13/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
10.2%
5/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Bilirubin
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Lipase
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
24.5%
12/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
24.5%
12/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
55.1%
27/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Cpk
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
14/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.8%
20/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
34.7%
17/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
24.5%
12/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis-Deep Connective Tissue
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
18.4%
9/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
10.2%
5/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Mood Alteration - Depression
|
14.3%
7/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Tremor
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Somnolence
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Cognitive Disturbance
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Confusion
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Memory Impairment
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Dizziness
|
12.2%
6/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Neuropathy-Sensory
|
36.7%
18/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Nervous system disorders
Neuropathy-Motor
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Eye disorders
Watery Eye
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Eye disorders
Cataract
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Eye disorders
Flashing Lights/Floaters
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Eye disorders
Blurred Vision
|
16.3%
8/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Urethra
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Perineum
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Pelvis
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Vagina
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Chest Wall
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Larynx
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Head/Headache
|
30.6%
15/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Extremity-Limb
|
14.3%
7/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Back
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Joint
|
24.5%
12/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Bone
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Bladder
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Pain Nos
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Stomach
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Rectum
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Oral Cavity
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Abdominal Pain Nos
|
34.7%
17/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Scalp
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Oral - Gums
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Middle Ear
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: External Ear
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Face
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Muscle
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Pain: Anus
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
8.2%
4/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.7%
18/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.1%
3/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.7%
18/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Cystitis
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Urinary Retention
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Bladder Spasm
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Renal and urinary disorders
Urinary Frequency
|
18.4%
9/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Reproductive system and breast disorders
Vaginitis
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
General disorders
Flu-Like Syndrome
|
2.0%
1/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
4.1%
2/49 • All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60