Trial Outcomes & Findings for Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary (NCT NCT00748657)
NCT ID: NCT00748657
Last Updated: 2019-07-23
Results Overview
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels
Results posted on
2019-07-23
Participant Flow
The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010).
Participant milestones
| Measure |
Bevacizumab
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=36 Participants
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Age, Customized
20-29
|
0 participants
n=93 Participants
|
|
Age, Customized
30-39
|
1 participants
n=93 Participants
|
|
Age, Customized
40-49
|
8 participants
n=93 Participants
|
|
Age, Customized
50-59
|
12 participants
n=93 Participants
|
|
Age, Customized
60-69
|
11 participants
n=93 Participants
|
|
Age, Customized
70-79
|
4 participants
n=93 Participants
|
|
Age, Customized
80-89
|
0 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levelsPopulation: Eligible and Treated Patients
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Outcome measures
| Measure |
Bevacizumab
n=36 Participants
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Tumor Response
|
16.7 percentage of patients
Interval 7.5 to 30.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levelsPopulation: Eligible and Treated Patients
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Outcome measures
| Measure |
Bevacizumab
n=36 Participants
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
9.3 Months
Interval 4.1 to 15.0
|
—
|
—
|
—
|
—
|
—
|
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=36 Participants
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
NA Months
Interval 44.9 to
NA (not available): median OS was not reached but is \>65.9 months, as is the upper bound of the 95% CI.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and evaluable patients
Adverse Events at least possibly related to study agent.
Outcome measures
| Measure |
Bevacizumab
n=36 Participants
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
Grade 1 (CTCAE v 3.0)
n=36 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=36 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=36 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=36 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
n=36 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Allergy/Immunology
|
23 Participants
|
11 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Auditory/Ear
|
29 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Cardiac
|
15 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Leukopenia
|
32 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Thrombocytopenia
|
28 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Anemia
|
21 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Coagulation
|
35 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Dermatologic
|
17 Participants
|
14 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Gastrointestinal
|
6 Participants
|
10 Participants
|
15 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Metabolic
|
13 Participants
|
10 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Musculoskeletal
|
30 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Neurosensory
|
21 Participants
|
13 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Other Neurological
|
22 Participants
|
12 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Pulmonary
|
12 Participants
|
20 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Sexual/Reproductive
|
32 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Syndromes
|
35 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Vascular
|
35 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Death, Not CTC coded
|
35 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Other Hematologic
|
33 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Constitutional
|
12 Participants
|
10 Participants
|
13 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Endocrine
|
33 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Genitourinary/Renal
|
29 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Hemorrhage
|
17 Participants
|
18 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Infection
|
23 Participants
|
0 Participants
|
11 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Lymphatics
|
31 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Ocular/Visual
|
30 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Pain
|
1 Participants
|
11 Participants
|
16 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Bevacizumab
Serious events: 13 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab
n=36 participants at risk
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypertension
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Ulcer,gi - Stomach
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Taste Alteration
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Abdominal Pain Nos
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Tumor
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
Other adverse events
| Measure |
Bevacizumab
n=36 participants at risk
Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
|
|---|---|
|
Immune system disorders
Allergy/Immunology - Other
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Immune system disorders
Rhinitis
|
30.6%
11/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
6/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Platelets
|
22.2%
8/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Leukocytes
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
41.7%
15/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Palpitations
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Ventricular Arrhythmia - Tachycardia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Hypertension
|
44.4%
16/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Pericardial Effusion
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Inr
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Constitutional Symptoms - Other
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Sweating
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Weight Gain
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Fever
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Weight Loss
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Rigors/Chills
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Fatigue
|
63.9%
23/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Insomnia
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
12/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
19.4%
7/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hot Flashes
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Heartburn
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Ulcer,gi - Stomach
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dysphagia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Distention
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Taste Alteration
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dry Mouth
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomiting
|
36.1%
13/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Anorexia
|
27.8%
10/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dehydration
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
50.0%
18/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
61.1%
22/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
36.1%
13/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage/Pulmonary - Bronchopulmonary Nos
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
41.7%
15/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hematoma
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ureter
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Edema: Limb
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Ast
|
19.4%
7/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Gfr
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Proteinuria
|
16.7%
6/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Creatinine
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Ggt
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alt
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Bilirubin
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.6%
11/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.2%
8/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neurology - Other
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration - Depression
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
19.4%
7/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration - Agitation
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Memory Impairment
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Dizziness
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy-Sensory
|
41.7%
15/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Watery Eye
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Dry Eye
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Photophobia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Flashing Lights/Floaters
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Blurred Vision
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain - Other
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Urethra
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Pelvis
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Vagina
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Chest /Thorax Nos
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Chest Wall
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Head/Headache
|
63.9%
23/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Neck
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Extremity-Limb
|
19.4%
7/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Back
|
19.4%
7/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Joint
|
25.0%
9/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Kidney
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Bladder
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Pain Nos
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Stomach
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Oral Cavity
|
11.1%
4/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Abdominal Pain Nos
|
50.0%
18/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Oral - Gums
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Skin
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Middle Ear
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Face
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Tumor
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Liver
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Muscle
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
8.3%
3/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
19.4%
7/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
19.4%
7/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
6/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.6%
11/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Cystitis
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Incontinence, Urinary
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Frequency
|
13.9%
5/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Libido
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.6%
2/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Flu-Like Syndrome
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
2.8%
1/36 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related 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