Trial Outcomes & Findings for Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT NCT00022659)
NCT ID: NCT00022659
Last Updated: 2019-07-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Every other 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 8/25/2004 (suspended from 10/6/2003 to 12/1/2003).
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
|
64
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
2
|
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 primary
|
1
|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=62 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
|
Age, Customized
10-19 years
|
1 participants
n=99 Participants
|
|
Age, Customized
20-29 years
|
1 participants
n=99 Participants
|
|
Age, Customized
30-39 years
|
3 participants
n=99 Participants
|
|
Age, Customized
40-49 years
|
13 participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
21 participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
13 participants
n=99 Participants
|
|
Age, Customized
70-79 years
|
10 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=99 Participants
|
|
Histologic Type
Adenocarcinoma, Unspecified
|
1 participants
n=99 Participants
|
|
Histologic Type
Clear Cell Carcinoma
|
2 participants
n=99 Participants
|
|
Histologic Type
Endometrioid Adenocarcinoma
|
2 participants
n=99 Participants
|
|
Histologic Type
Mixed Epithelial Carcinoma
|
6 participants
n=99 Participants
|
|
Histologic Type
Serous Adenocarcinoma
|
51 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Every other cycle for 6 months.Population: 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=62 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
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
|
|---|---|---|---|---|
|
Progression-free Survival at 6 Months
|
40.3 percentage of participants
Interval 29.8 to 53.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years.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=62 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
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
|
|---|---|---|---|---|
|
Tumor Response
|
21 percentage of participants
Interval 12.6 to 31.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years.Population: Eligible and evaluable patients
Outcome measures
| Measure |
Bevacizumab
n=62 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
Grade 2 (CTCAE v 2.0)
n=62 Participants
Number of patients who experienced a grade 2 event using Common Toxicity Criteria version 2.0
|
Grade 3 (CTCAE v 2.0)
n=62 Participants
Number of patients who experienced a grade 3 event using Common Toxicity Criteria version 2.0
|
Grade 4 (CTCAE v 2.0)
n=62 Participants
Number of patients who experienced a grade 4 event using Common Toxicity Criteria version 2.0
|
|---|---|---|---|---|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Leukopenia
|
18 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Thrombocytopenia
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Neutropenia
|
6 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Anemia
|
18 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Hematologic
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Allergy
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Hearing
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Cardiovascular
|
12 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Coagulation
|
9 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Constitutional
|
22 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Dermatologic
|
10 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Endocrine
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Gastrointestinal
|
26 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Genitourinary/Renal
|
5 Participants
|
14 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Hemorrhage
|
14 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Hepatic
|
19 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Infection
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Lymphatics
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Musculoskeletal
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Metabolic
|
17 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Neurologic
|
16 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Ocular
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Pain
|
26 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Pulmonary
|
6 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.
Sexual/Reproductive
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
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=62 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
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
|
|---|---|---|---|---|
|
Overall Survival
|
16.9 months
Interval 11.8 to 27.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years.Population: 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=62 Participants
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
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
|
|---|---|---|---|---|
|
Duration of Progression-free Survival
|
4.7 months
Interval 2.7 to 12.9
|
—
|
—
|
—
|
Adverse Events
Bevacizumab
Serious events: 26 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=62 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 Reaction
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Hematologic Other
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Edema
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Thrombosis Embolism
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Ischemia/Cardiac Infarction
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Partial Thromboplastin Time
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Weight Gain(No Vod)
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomitting
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Gi Other
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Melena/Gi Bleeding
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Abdominal Pain
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Pain Tumor
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Stridor/Larynx
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
Other adverse events
| Measure |
Bevacizumab
n=62 participants at risk
Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Endocrine disorders
Hot Flashes/Flushes
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Anorexia
|
19.4%
12/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Hematologic Other
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Conduction Abnorm Atrioventricular Block
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypotension
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Sinus Tachycardia
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Arrhythmia Super Ventricular
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Phlebitis Superficial
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Sinus Bradycardia
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Edema
|
16.1%
10/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Thrombosis Embolism
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypertension
|
29.0%
18/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Palpitations
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Cardiac disorders
Ischemia/Cardiac Infarction
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Prothrombin Time
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Coagulation Other
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Partial Thromboplastin Time
|
16.1%
10/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Fever(No Neutropenia)
|
8.1%
5/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Weight Loss
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Rigors Chills
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Weight Gain(No Vod)
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Sweating
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Fatigue
|
64.5%
40/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.7%
6/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Rash Desquamation
|
11.3%
7/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Skin Other
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Pigmentation Changes
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Bruising
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Immune system disorders
Allergic Rhinitis
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
Immune system disorders
Allergic Reaction
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Inner Ear/Hearing
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Middle Ear/Hearing
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.0%
13/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.5%
22/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Transfusion Prbc's
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Anemia
|
48.4%
30/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea With Colostomy
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mouth Dryness
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Ileus
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Ascites Non-Malignant
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Proctitis
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dyspepsia/Heartburn
|
16.1%
10/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Taste Disturbance
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dysphagia Esophagitis Odynophagia
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea Without Colostomy
|
29.0%
18/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
38.7%
24/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Stomatitis/Pharyngitis
|
17.7%
11/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dehydration
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomitting
|
33.9%
21/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
43.5%
27/62 • 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) up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Gi Other
|
21.0%
13/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage Other
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Rectal Bleeding/Hematochezia
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Epistaxis
|
9.7%
6/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Melena/Gi Bleeding
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage Without Grade 3/4 Thrombocytopenia
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Vaginal Bleeding
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Vascular disorders
Hematuria No Vaginal Bleeding
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Ggt(Gamma-Glutamyltranspeptidase)
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Hepatic Other
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
19.4%
12/62 • 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) up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Sgot(Alt)
|
17.7%
11/62 • 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) up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Sgot(Ast)
|
30.6%
19/62 • 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) up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Alkaline Phosphatase
|
27.4%
17/62 • 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) up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Bilirubin
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Infections and infestations
Infection Without Neutropenia
|
41.9%
26/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Lymphatics Other
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Lymphatics
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alkalosis
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Metabolic Other
|
22.6%
14/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.7%
11/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypertyiglyceridemia
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Bicarbonate
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.7%
6/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.8%
16/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.1%
5/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesmia
|
19.4%
12/62 • 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) up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Other
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.3%
7/62 • 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) up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Extrapyramidal
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Vertigo
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration Anxeity/Agitation
|
25.8%
16/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Memory Loss
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Insomnia
|
9.7%
6/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Dizziness
|
14.5%
9/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration Depression
|
14.5%
9/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy Sensor
|
24.2%
15/62 • 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) up to 5 years after stopping study treatment
|
|
Nervous system disorders
Pyramidal Tract Dysfunction
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Eye disorders
Glaucoma
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Eye disorders
Ocular Other
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Eye disorders
Tearing
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Eye disorders
Dry Eye
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
Eye disorders
Cataract
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Eye disorders
Vision Blurres
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Abdominal Pain
|
46.8%
29/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Pain Other
|
22.6%
14/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Pain Tumor
|
8.1%
5/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Pleuritic Pain
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Neuropathic Pain
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Earache
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Dyspareunia
|
3.2%
2/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Headache
|
30.6%
19/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Pelvic Pain
|
11.3%
7/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Chest Pain
|
9.7%
6/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Bone Pain
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Arthralgia
|
22.6%
14/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Myalgia
|
27.4%
17/62 • 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) up to 5 years after stopping study treatment
|
|
General disorders
Pain Rectal/Perirectal
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes/Stridor/Larynx
|
11.3%
7/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Other
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
8/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Ards
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/Pulmonary Infiltrates
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.8%
16/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
8.1%
5/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Dysuria
|
8.1%
5/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Creatinine
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Renal/Gu Other
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Vaginitis No Infection
|
6.5%
4/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Ureteral Obstruction
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Incontinence
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Bladder Spasms
|
1.6%
1/62 • 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) up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Proteinuria
|
35.5%
22/62 • 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) up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
4.8%
3/62 • 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) up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Libido
|
1.6%
1/62 • 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) 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