Trial Outcomes & Findings for Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix (NCT NCT00025233)
NCT ID: NCT00025233
Last Updated: 2019-07-24
Results Overview
Whether or not the patient survived progression-free for at least 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Every other 3-week treatment cycle for 6 months
Results posted on
2019-07-24
Participant Flow
The study was activated on 4/29/2002 and closed to accrual on 11/6/2006 (suspended from 2/7/2005 to 10/30/2005).
Patients must have persistent or recurrent squamous cell carcinoma of the cervix with documented disease progression. Patients were required to have measurable disease at time of study entry. They were required to have had a prior cytotoxic regimen.
Participant milestones
| Measure |
Bevacizumab
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Bevacizumab
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Ineligible: wrong cell type
|
1
|
|
Overall Study
Ineligible: wrong primary
|
1
|
|
Overall Study
Ineligible: improper prior treatment
|
1
|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
Bevacizumab in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Age, Customized
20-29 years
|
1 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
11 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
17 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
12 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
|
Histologic Type
Adenosquamous
|
3 participants
n=5 Participants
|
|
Histologic Type
Squamous Cell Carcinoma
|
43 participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage
Unspecified
|
1 participants
n=5 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Stage
Recurrent/Persistent
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every other 3-week treatment cycle for 6 monthsPopulation: Eligible and Treated Patients
Whether or not the patient survived progression-free for at least 6 months.
Outcome measures
| Measure |
Bevacizumab
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 2.0)
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2 (CTCAE v 2.0)
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
Grade 5 (CTCAE v 2.0)
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival Greater Than 6 Months
|
23.9 percentage of participants
Interval 14.0 to 36.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every cycle and 30 days after the end of treatment. (average 5 months)Population: Eligible and treated patients
The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.
Outcome measures
| Measure |
Bevacizumab
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 2.0)
n=46 Participants
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2 (CTCAE v 2.0)
n=46 Participants
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
n=46 Participants
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
n=46 Participants
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
Grade 5 (CTCAE v 2.0)
n=46 Participants
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|---|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Infection
|
40 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Pulmonary
|
38 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Leukopenia
|
39 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Thrombocytopenia
|
43 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Neutropenia
|
42 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Anemia
|
26 Participants
|
8 Participants
|
10 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Other hematologic
|
41 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Allergy
|
45 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Hypertension
|
33 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Thrombosis Embolism
|
41 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Other cardiovascular
|
34 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Coagulation
|
43 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Constitutional
|
22 Participants
|
16 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Dermatologic
|
36 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Gastrointestinal
|
25 Participants
|
7 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Genitourinary/renal
|
34 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Hemorrhage
|
38 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Hepatic
|
35 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Metabolic
|
29 Participants
|
16 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Neuropathy sensory
|
41 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Other neurologic
|
41 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
Pain
|
27 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months)Population: Eligible and treated patients.
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
Bevacizumab
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 2.0)
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2 (CTCAE v 2.0)
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
Grade 5 (CTCAE v 2.0)
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|---|
|
Tumor Response
|
10.9 percentage of participants
Interval 4.4 to 21.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 years.Population: 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
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 2.0)
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2 (CTCAE v 2.0)
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
Grade 5 (CTCAE v 2.0)
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
7.3 months
Interval 6.1 to 10.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 yearsPopulation: Eligible and treated patients
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Bevacizumab
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 2.0)
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2 (CTCAE v 2.0)
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
Grade 5 (CTCAE v 2.0)
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|---|
|
Duration of Progression-free Survival
|
3.40 months
Interval 2.53 to 4.53
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients.
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Outcome measures
| Measure |
Bevacizumab
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 2.0)
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2 (CTCAE v 2.0)
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
Grade 5 (CTCAE v 2.0)
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|---|
|
Performance Status
Performance Status 0
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Performance Status
Performance Status 1
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Performance Status
Performance Status 2
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
Outcome measures
| Measure |
Bevacizumab
n=46 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 1 (CTCAE v 2.0)
Number of patients who experienced a grade 1 event using Common Toxicity Criteria version 2.0
|
Grade 2 (CTCAE v 2.0)
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
Grade 5 (CTCAE v 2.0)
Number of patients who experienced a grade 5 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|---|---|
|
Age at Enrollment
20-29 years
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Age at Enrollment
30-39 years
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Age at Enrollment
40-49 years
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Age at Enrollment
50-59 years
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Age at Enrollment
60-69 years
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Bevacizumab
Serious events: 27 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=46 participants at risk
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Thrombosis Embolism
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Hypertension
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Constitutional Symptoms Other
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Fatigue
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Abdominal Pain
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Pain other
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Diarrhea Without Colostomy
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Melena/Gi Bleeding
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Vaginal Bleeding
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Infection With Grade 3/4 Neutropenia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Mood Alteration Depression
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Creatinine
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Sinus Tachychardia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Pelvic Pain
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Bone Pain
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Myalgia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Renal/Gu Other
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Ureteral Obstruction
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Rectal Bleeding/Hematochezia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
Other adverse events
| Measure |
Bevacizumab
n=46 participants at risk
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Immune system disorders
Allergic Rhinitis
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Immune system disorders
Allergic Reaction
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Ear and labyrinth disorders
Inner Ear/Hearing
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Ear and labyrinth disorders
Middle Ear/Hearing
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.7%
10/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Transfusion Prbc's
|
26.1%
12/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
71.7%
33/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Transfusion Platelets
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Blood and lymphatic system disorders
Lymphatics Other
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Cardiac Left Ventricular Function
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Arrhythmia Nodal/Junctional Dysrhythmia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Edema
|
23.9%
11/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Thrombosis Embolism
|
13.0%
6/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Hypertension
|
32.6%
15/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Palpitations
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Prothrombin Time
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Coagulation Other
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Partial Thromboplastin Time
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Rectal Bleeding/Hematochezia
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Epistaxis
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Vaginal Bleeding
|
21.7%
10/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hematuria No Vaginal Bleeding
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hemoptysis
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Fever(No Neutropenia)
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Weight Loss
|
17.4%
8/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Rigors Chills
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Constitutional Symptoms Other
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Sweating
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Fatigue
|
73.9%
34/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Abdominal Pain
|
45.7%
21/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Pain Other
|
41.3%
19/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Pain Tumor
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Neuropathic Pain
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Earache
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Dyspareunia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Headache
|
17.4%
8/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Pelvic Pain
|
23.9%
11/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Chest Pain
|
13.0%
6/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Bone Pain
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Arthralgia
|
26.1%
12/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Myalgia
|
21.7%
10/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
General disorders
Pain Rectal/Perirectal
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.9%
11/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Desquamation
|
19.6%
9/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Other
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Wound Not-Infectious
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Pigmentation Changes
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Wound Infectious
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Endocrine disorders
Hot Flashes/Flushes
|
13.0%
6/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Anorexia
|
41.3%
19/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Fistula Intestinal
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Mouth Dryness
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Proctitis
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dyspepsia/Heartburn
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Fistula Rectal/Anal
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Taste Disturbance
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Diarrhea Without Colostomy
|
19.6%
9/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Constipation
|
45.7%
21/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Stomatitis/Pharyngitis
|
17.4%
8/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dehydration
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
26.1%
12/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Nausea
|
41.3%
19/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Gi Other
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
19.6%
9/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Hepatobiliary disorders
Sgot(Alt)
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Hepatobiliary disorders
Sgot(Ast)
|
19.6%
9/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Hepatobiliary disorders
Alkaline Phosphatase
|
28.3%
13/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Hepatobiliary disorders
Bilirubin
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Infection No Anc
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Infection Without Neutropenia
|
37.0%
17/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Metabolic Other
|
23.9%
11/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.6%
15/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.3%
19/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
13.0%
6/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.6%
9/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesmia
|
23.9%
11/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Muscle Weakness
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Speech Impairment
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Hallucinations
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Extrapyramidal
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Depressed Level Of Consciousness
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Confusion
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Mood Alteration Anxiety/Agitation
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Memory Loss
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Insomnia
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Dizziness
|
10.9%
5/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Mood Alteration Depression
|
17.4%
8/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neuropathy Sensor
|
34.8%
16/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neuropathy Motor
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Eye disorders
Ocular Other
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Eye disorders
Tearing
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Eye disorders
Keratitis
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Eye disorders
Conjunctivitis
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Eye disorders
Vision Flashing Lights/Floaters
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Eye disorders
Double Vision
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Stridor/Larynx
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
7/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.4%
14/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Dysuria
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Creatinine
|
23.9%
11/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Renal/Gu Other
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Retention
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Ureteral Obstruction
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Incontinence
|
8.7%
4/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Hemoglobinuria
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Fistula
|
2.2%
1/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Bladder Spasms
|
6.5%
3/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
21.7%
10/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Libido
|
4.3%
2/46 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) for up to 5 years after stopping study treatment.
|
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