Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00565851
Collaborator
NRG Oncology (Other)
1,052
718
4
1.5
Study Details
Study Description
Brief Summary
This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.
Detailed Description
PRIMARY OBJECTIVES:
-
To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases the duration of overall survival in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.
-
To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases the duration of overall survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.
SECONDARY OBJECTIVES:
-
To determine if the addition of bevacizumab to the second-line and maintenance phase of treatment increases the duration of progression-free survival relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.
-
To prospectively determine the incidence of carboplatin and paclitaxel hypersensitivity in these patients undergoing retreatment with both agents as first recurrence therapy.
-
To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy increases quality of life (QOL) in patients with recurrent platinum-sensitive epithelial ovarian cancer, peritoneal primary or fallopian tube cancer, as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) trial outcome index and Rand Short Form (SF)-36 physical functioning scale.
-
To determine if the addition of bevacizumab to the second-line and maintenance phases of treatment increases QOL relative to second-line paclitaxel and carboplatin alone in patients with recurrent platinum-sensitive epithelial ovarian, peritoneal primary or fallopian tube cancer.
TRANSLATIONAL RESEARCH OBJECTIVES:
-
To define molecular and biochemical profiles associated with the duration of progression-free survival in platinum-sensitive recurrent ovarian, peritoneal primary or fallopian tube carcinoma treated with combination chemotherapy with or without bevacizumab followed with or without maintenance bevacizumab therapy in the presence or absence of secondary surgical cytoreduction.
-
To identify molecular determinants that predict sensitivity or resistance to carboplatin and paclitaxel with or without bevacizumab followed with or without maintenance bevacizumab therapy.
-
To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.
OUTLINE: Patients are assigned to 1 of 4 treatment groups. Patients who are not candidates for surgical cytoreduction (i.e., those for whom complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking) are eligible to receive chemotherapy after randomization.
Patients who are eligible for surgery undergo abdominal exploration with cytoreduction. Patients are then randomized to 1 of 4 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or docetaxel IV over 1 hour and carboplatin IV over 60 minutes on day 1.
ARM II: Patients receive chemotherapy as in Arm I and bevacizumab IV over 30-90 minutes on day 1.
ARM III: Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I.
ARM IV: Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II.
In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of therapy. Patients with stable disease or partial regression receive a maximum of 8 courses.
Patients without measurable lesions as determined by a computed tomography (CT) scan prior to initiating study treatment continue therapy for 6 courses or, if cancer antigen (CA)-125 normalizes, for 2 courses beyond CA-125 normalization, whichever is greater. Patients in Arm II then receive a maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment with bevacizumab alone repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1052 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865)
Actual Study Start Date
:
Dec 6, 2007
Actual Primary Completion Date
:
Apr 30, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm I (paclitaxel, docetaxel, carboplatin) Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. |
Drug: Carboplatin
Given IV
Other Names:
Drug: Docetaxel
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Experimental: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab) Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. |
Biological: Bevacizumab
Given IV
Other Names:
Drug: Carboplatin
Given IV
Other Names:
Drug: Docetaxel
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Experimental: Arm III (gemcitabine hydrochloride, carboplatin) Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and carboplatin as in Arm I. |
Drug: Carboplatin
Given IV
Other Names:
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Experimental: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and carboplatin IV as in Arm II. |
Biological: Bevacizumab
Given IV
Other Names:
Drug: Carboplatin
Given IV
Other Names:
Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer [The time frame is 82.5 months (median duration of follow-up)]
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
- To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer [The time frame is 82.5 months (median duration of follow-up).]
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Secondary Outcome Measures
- Progression-free Survival (Chemotherapy Analysis) [Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase]
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
- Progression Free Survival (Surgery Analysis) [Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.]
Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
- Summary of Adverse Events (CTCAE Version 4.0) [During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months]
Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))
- Patient Reported Quality of Life (Chemotherapy Analysis) [1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.]
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
- Patient Reported Physical Function (Chemotherapy Analysis) [1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.]
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning.
- Patient Reported Quality of Life (Surgery Analysis) [1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.]
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
- Patient Reported Physical Functioning (Surgery Analysis) [1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery]
Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery and consent to have their surgical treatment determined by randomization
-
Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
-
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
-
Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles)
-
A complete response to front-line chemotherapy must include: negative physical exam, negative pelvic exam and normalization of CA125, if elevated at baseline; although not required, any radiographic assessment of disease status (e.g. CT, magnetic resonance imaging [MRI], positron emission tomography [PET]/CT, etc) obtained following the completion of primary therapy should be considered negative for disease
-
All patients must have also had a treatment-free interval without clinical evidence of progressive disease of at least 6 months from completion of front-line chemotherapy (both platinum and taxane); front-line therapy may have included a biologic agent (i.e. bevacizumab)
-
Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy
-
Patients must have clinically evident recurrent disease for the purpose of this study
-
Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be more than or equal to 20 mm when measured by conventional techniques, MRI or CT, or more than or equal to 10 mm when measured by spiral CT
-
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to Common Toxicity Criteria for Adverse Events version (v)4.0 (CTCAE) grade 1
-
Platelets greater than or equal to 100,000/mm^3 (CTCAE grade 0-1)
-
Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1
-
Total bilirubin =< 1.5 ULN (CTCAE grade 1)
-
Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal in the absence of liver metastasis; SGOT/AST < 5.0 times ULN in the presence of liver metastasis
-
Alkaline phosphatase =< 2.5 times the upper limit of normal in the absence of liver metastasis; alkaline phosphatase < 5.0 times ULN in the presence of liver metastasis
-
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL
-
This eligibility criterion does not apply to patients enrolled after August 28, 2011; patients who are not candidates for surgical cytoreduction are eligible for the chemotherapy randomization; patients are not considered candidates for surgical cytoreduction if complete cytoreduction in the estimation of the investigator is impossible or a medical infirmity precludes exploration and debulking
-
Patients must have met the pre-entry requirements as specified
-
Patients must have signed an approved informed consent and authorization permitting release of personal health information
-
Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
Exclusion Criteria:
-
Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
-
Patients receiving concurrent immunotherapy, or radiotherapy
-
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
-
Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded
-
Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed above
-
Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation
-
Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian tube, and primary peritoneal) are excluded
-
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
-
Patients with uncontrolled infection
-
Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
-
Patients with >= grade 2 peripheral neuropathy
-
Patients with a history of allergic reactions to carboplatin and/or paclitaxel or chemically similar compounds; patients with allergic (hypersensitivity) reactions to these chemotherapeutic agents are NOT excluded IF they were successfully retreated following a desensitization program or protocol
-
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
-
Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant or patients who are nursing are not eligible for this trial; to date, no fetal studies in animal or humans have been performed; the possibility of harm to a fetus is likely; bevacizumab specifically inhibits VEGF, which is responsible for the formation of new blood vessels during development, and antibodies can cross the placenta; therefore, bevacizumab should not be administered to pregnant women; in addition, there are unknown immediate and long-term consequences of chemotherapy administration to these women; in addition, surgical exploration as mandated by randomization during pregnancy may cause imminent mortal consequences; further, it is not known whether bevacizumab is excreted in human milk; because many drugs are excreted in human milk, bevacizumab should not be administered to nursing women; subjects will be apprised of the large potential risk to a developing fetus
-
Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
-
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
-
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with a history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or a history of stroke within 5 years of the first date of treatment on this study
-
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with clinically significant cardiovascular disease; this includes:
-
Patients with significant cardiac conduction abnormalities, i.e. PR interval > 0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block
-
Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
-
Myocardial infarction, cardiac arrhythmia or unstable angina < 6 months prior to registration
-
New York Heart Association (NYHA) grade II or greater congestive heart failure
-
Serious cardiac arrhythmia requiring medication
-
Grade II or greater peripheral vascular disease (exception: episodes of ischemia < 24 hours [hrs] in duration, that are managed non-surgically and without permanent deficit)
-
History of cerebrovascular attack (CVA) within six months
-
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
-
Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with bevacizumab on cycle #2
-
Patients undergoing pre-treatment surgery for purposes other than cytoreduction may also participate provided they meet eligibility; patients randomized to arms containing bevacizumab must wait a minimum of 28 days since that procedure to begin protocol treatment; patients who undergo an uncomplicated port placement must wait a minimum of 7 days to begin protocol treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anchorage Associates in Radiation Medicine | Anchorage | Alaska | United States | 98508 |
| 2 | Anchorage Radiation Therapy Center | Anchorage | Alaska | United States | 99504 |
| 3 | Alaska Breast Care and Surgery LLC | Anchorage | Alaska | United States | 99508 |
| 4 | Alaska Oncology and Hematology LLC | Anchorage | Alaska | United States | 99508 |
| 5 | Alaska Regional Hospital | Anchorage | Alaska | United States | 99508 |
| 6 | Alaska Women's Cancer Care | Anchorage | Alaska | United States | 99508 |
| 7 | Anchorage Oncology Centre | Anchorage | Alaska | United States | 99508 |
| 8 | Katmai Oncology Group | Anchorage | Alaska | United States | 99508 |
| 9 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 10 | CHI Saint Vincent Cancer Center Hot Springs | Hot Springs | Arkansas | United States | 71913 |
| 11 | Sutter Auburn Faith Hospital | Auburn | California | United States | 95602 |
| 12 | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | United States | 95603 |
| 13 | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | United States | 94704 |
| 14 | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | United States | 91505 |
| 15 | Mills-Peninsula Medical Center | Burlingame | California | United States | 94010 |
| 16 | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | United States | 95682 |
| 17 | John Muir Medical Center-Concord Campus | Concord | California | United States | 94520 |
| 18 | Sutter Davis Hospital | Davis | California | United States | 95616 |
| 19 | UC San Diego Moores Cancer Center | La Jolla | California | United States | 92093 |
| 20 | Long Beach Memorial Medical Center-Todd Cancer Institute | Long Beach | California | United States | 90806 |
| 21 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 22 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
| 23 | Memorial Medical Center | Modesto | California | United States | 95355 |
| 24 | Palo Alto Medical Foundation-Camino Division | Mountain View | California | United States | 94040 |
| 25 | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California | United States | 94040 |
| 26 | Sutter Cancer Research Consortium | Novato | California | United States | 94945 |
| 27 | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 28 | Palo Alto Medical Foundation Health Care | Palo Alto | California | United States | 94301 |
| 29 | Stanford Cancer Institute Palo Alto | Palo Alto | California | United States | 94304 |
| 30 | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | United States | 95661 |
| 31 | Sutter Roseville Medical Center | Roseville | California | United States | 95661 |
| 32 | Sutter Medical Center Sacramento | Sacramento | California | United States | 95816 |
| 33 | California Pacific Medical Center-Pacific Campus | San Francisco | California | United States | 94115 |
| 34 | UCSF Medical Center-Mount Zion | San Francisco | California | United States | 94115 |
| 35 | Palo Alto Medical Foundation-Santa Cruz | Santa Cruz | California | United States | 95065 |
| 36 | Sutter Pacific Medical Foundation | Santa Rosa | California | United States | 95403 |
| 37 | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California | United States | 94086 |
| 38 | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California | United States | 95687 |
| 39 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
| 40 | John Muir Medical Center-Walnut Creek | Walnut Creek | California | United States | 94598 |
| 41 | Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | United States | 80012 |
| 42 | The Medical Center of Aurora | Aurora | Colorado | United States | 80012 |
| 43 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 44 | Boulder Community Hospital | Boulder | Colorado | United States | 80301 |
| 45 | Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | United States | 80304 |
| 46 | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | United States | 80907 |
| 47 | Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado | United States | 80907 |
| 48 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
| 49 | Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
| 50 | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | United States | 80218 |
| 51 | Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | United States | 80218 |
| 52 | SCL Health Saint Joseph Hospital | Denver | Colorado | United States | 80218 |
| 53 | Rocky Mountain Cancer Centers-Rose | Denver | Colorado | United States | 80220 |
| 54 | Rose Medical Center | Denver | Colorado | United States | 80220 |
| 55 | Western States Cancer Research NCORP | Denver | Colorado | United States | 80222 |
| 56 | Mercy Medical Center | Durango | Colorado | United States | 81301 |
| 57 | Southwest Oncology PC | Durango | Colorado | United States | 81301 |
| 58 | Rocky Mountain Gynecologic Oncology PC | Englewood | Colorado | United States | 80110 |
| 59 | Mountain Blue Cancer Care Center - Swedish | Englewood | Colorado | United States | 80113 |
| 60 | Swedish Medical Center | Englewood | Colorado | United States | 80113 |
| 61 | Mountain Blue Cancer Care Center | Golden | Colorado | United States | 80401 |
| 62 | Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | United States | 81501 |
| 63 | North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
| 64 | Rocky Mountain Cancer Centers-Greenwood Village | Greenwood Village | Colorado | United States | 80111 |
| 65 | Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado | United States | 80228 |
| 66 | Saint Anthony Hospital | Lakewood | Colorado | United States | 80228 |
| 67 | Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | United States | 80120 |
| 68 | Littleton Adventist Hospital | Littleton | Colorado | United States | 80122 |
| 69 | Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | United States | 80124 |
| 70 | Sky Ridge Medical Center | Lone Tree | Colorado | United States | 80124 |
| 71 | Longmont United Hospital | Longmont | Colorado | United States | 80501 |
| 72 | Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado | United States | 80501 |
| 73 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
| 74 | Parker Adventist Hospital | Parker | Colorado | United States | 80138 |
| 75 | Rocky Mountain Cancer Centers-Parker | Parker | Colorado | United States | 80138 |
| 76 | Saint Mary Corwin Medical Center | Pueblo | Colorado | United States | 81004 |
| 77 | Rocky Mountain Cancer Centers - Pueblo | Pueblo | Colorado | United States | 81008 |
| 78 | North Suburban Medical Center | Thornton | Colorado | United States | 80229 |
| 79 | Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado | United States | 80260 |
| 80 | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
| 81 | Hartford HealthCare - Saint Vincent's Medical Center | Bridgeport | Connecticut | United States | 06606 |
| 82 | University of Connecticut | Farmington | Connecticut | United States | 06030 |
| 83 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 84 | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | United States | 06105 |
| 85 | Middlesex Hospital | Middletown | Connecticut | United States | 06457 |
| 86 | The Hospital of Central Connecticut | New Britain | Connecticut | United States | 06050 |
| 87 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 88 | Christiana Gynecologic Oncology LLC | Newark | Delaware | United States | 19713 |
| 89 | Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | United States | 19713 |
| 90 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 91 | Medical Oncology Hematology Consultants PA | Newark | Delaware | United States | 19713 |
| 92 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
| 93 | Beebe Health Campus | Rehoboth Beach | Delaware | United States | 19971 |
| 94 | TidalHealth Nanticoke / Allen Cancer Center | Seaford | Delaware | United States | 19973 |
| 95 | Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | United States | 19801 |
| 96 | MedStar Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 97 | AdventHealth Altamonte | Altamonte Springs | Florida | United States | 32701 |
| 98 | Florida Gynecologic Oncology | Fort Myers | Florida | United States | 33905 |
| 99 | AdventHealth Kissimmee | Kissimmee | Florida | United States | 34744 |
| 100 | AdventHealth Medical Group Urology at Orlando | Orlando | Florida | United States | 32803 |
| 101 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 102 | AdventHealth East Orlando | Orlando | Florida | United States | 32822 |
| 103 | Women's Cancer Associates | Saint Petersburg | Florida | United States | 33713 |
| 104 | AdventHealth Winter Park | Winter Park | Florida | United States | 32792 |
| 105 | Augusta University Medical Center | Augusta | Georgia | United States | 30912 |
| 106 | John B Amos Cancer Center | Columbus | Georgia | United States | 31904 |
| 107 | Dekalb Medical Center | Decatur | Georgia | United States | 30033 |
| 108 | Northeast Georgia Medical Center-Gainesville | Gainesville | Georgia | United States | 30501 |
| 109 | Low Country Cancer Care | Savannah | Georgia | United States | 31404 |
| 110 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 111 | Summit Cancer Care-Memorial | Savannah | Georgia | United States | 31404 |
| 112 | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | United States | 31405 |
| 113 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | United States | 83706 |
| 114 | Saint Luke's Cancer Institute - Boise | Boise | Idaho | United States | 83712 |
| 115 | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | United States | 83605 |
| 116 | Walter Knox Memorial Hospital | Emmett | Idaho | United States | 83617 |
| 117 | Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | United States | 83619 |
| 118 | Idaho Urologic Institute-Meridian | Meridian | Idaho | United States | 83642 |
| 119 | Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | United States | 83642 |
| 120 | Saint Alphonsus Medical Center-Nampa | Nampa | Idaho | United States | 83686 |
| 121 | Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | United States | 83686 |
| 122 | Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | United States | 83301 |
| 123 | Northwest Community Hospital | Arlington Heights | Illinois | United States | 60005 |
| 124 | Rush - Copley Medical Center | Aurora | Illinois | United States | 60504 |
| 125 | Saint Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
| 126 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
| 127 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 128 | Memorial Hospital of Carbondale | Carbondale | Illinois | United States | 62902 |
| 129 | SIH Cancer Institute | Carterville | Illinois | United States | 62918 |
| 130 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 131 | Centralia Oncology Clinic | Centralia | Illinois | United States | 62801 |
| 132 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 133 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 134 | University of Illinois | Chicago | Illinois | United States | 60612 |
| 135 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 136 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 137 | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | United States | 62526 |
| 138 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 139 | Carle Physician Group-Effingham | Effingham | Illinois | United States | 62401 |
| 140 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 141 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
| 142 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
| 143 | Western Illinois Cancer Treatment Center | Galesburg | Illinois | United States | 61401 |
| 144 | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | United States | 60134 |
| 145 | Sudarshan K Sharma MD Limited-Gynecologic Oncology | Hinsdale | Illinois | United States | 60521 |
| 146 | Duly Health and Care Joliet | Joliet | Illinois | United States | 60435 |
| 147 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 148 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 149 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 150 | Good Samaritan Regional Health Center | Mount Vernon | Illinois | United States | 62864 |
| 151 | UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | United States | 60451 |
| 152 | Cancer Care Center of O'Fallon | O'Fallon | Illinois | United States | 62269 |
| 153 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 154 | Radiation Oncology of Northern Illinois | Ottawa | Illinois | United States | 61350 |
| 155 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
| 156 | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | United States | 61554 |
| 157 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 158 | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | United States | 61615 |
| 159 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 160 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 161 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
| 162 | Valley Radiation Oncology | Peru | Illinois | United States | 61354 |
| 163 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
| 164 | Central Illinois Hematology Oncology Center | Springfield | Illinois | United States | 62702 |
| 165 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 166 | Springfield Clinic | Springfield | Illinois | United States | 62702 |
| 167 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 168 | Southwest Illinois Health Services LLP | Swansea | Illinois | United States | 62226 |
| 169 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 170 | The Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 171 | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | United States | 60555 |
| 172 | Rush-Copley Healthcare Center | Yorkville | Illinois | United States | 60560 |
| 173 | Elkhart Clinic | Elkhart | Indiana | United States | 46514-2098 |
| 174 | Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana | United States | 46514 |
| 175 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
| 176 | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 177 | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
| 178 | Community Howard Regional Health | Kokomo | Indiana | United States | 46904 |
| 179 | IU Health La Porte Hospital | La Porte | Indiana | United States | 46350 |
| 180 | Franciscan Saint Anthony Health-Michigan City | Michigan City | Indiana | United States | 46360 |
| 181 | Woodland Cancer Care Center | Michigan City | Indiana | United States | 46360 |
| 182 | Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana | United States | 46545 |
| 183 | Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana | United States | 46545 |
| 184 | The Community Hospital | Munster | Indiana | United States | 46321 |
| 185 | Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana | United States | 46563 |
| 186 | Reid Health | Richmond | Indiana | United States | 47374 |
| 187 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 188 | Michiana Hematology Oncology PC-South Bend | South Bend | Indiana | United States | 46601 |
| 189 | South Bend Clinic | South Bend | Indiana | United States | 46617 |
| 190 | Northern Indiana Cancer Research Consortium | South Bend | Indiana | United States | 46628 |
| 191 | Michiana Hematology Oncology PC-Westville | Westville | Indiana | United States | 46391 |
| 192 | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | United States | 50325 |
| 193 | Mercy Cancer Center-West Lakes | Clive | Iowa | United States | 50325 |
| 194 | Alegent Health Mercy Hospital | Council Bluffs | Iowa | United States | 51503 |
| 195 | Greater Regional Medical Center | Creston | Iowa | United States | 50801 |
| 196 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 197 | Iowa-Wide Oncology Research Coalition NCORP | Des Moines | Iowa | United States | 50309 |
| 198 | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | United States | 50309 |
| 199 | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | United States | 50314 |
| 200 | Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 201 | Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
| 202 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 203 | Abben Cancer Center | Spencer | Iowa | United States | 51301 |
| 204 | Methodist West Hospital | West Des Moines | Iowa | United States | 50266-7700 |
| 205 | Mercy Medical Center-West Lakes | West Des Moines | Iowa | United States | 50266 |
| 206 | Cancer Center of Kansas - Chanute | Chanute | Kansas | United States | 66720 |
| 207 | Cancer Center of Kansas - Dodge City | Dodge City | Kansas | United States | 67801 |
| 208 | Cancer Center of Kansas - El Dorado | El Dorado | Kansas | United States | 67042 |
| 209 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
| 210 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
| 211 | Providence Medical Center | Kansas City | Kansas | United States | 66112 |
| 212 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
| 213 | Cancer Center of Kansas-Kingman | Kingman | Kansas | United States | 67068 |
| 214 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
| 215 | Kansas Institute of Medicine Cancer and Blood Center | Lenexa | Kansas | United States | 66219 |
| 216 | Minimally Invasive Surgery Hospital | Lenexa | Kansas | United States | 66219 |
| 217 | Cancer Center of Kansas-Liberal | Liberal | Kansas | United States | 67905 |
| 218 | Cancer Center of Kansas-Manhattan | Manhattan | Kansas | United States | 66502 |
| 219 | Cancer Center of Kansas - McPherson | McPherson | Kansas | United States | 67460 |
| 220 | Cancer Center of Kansas - Newton | Newton | Kansas | United States | 67114 |
| 221 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
| 222 | Saint Luke's South Hospital | Overland Park | Kansas | United States | 66213 |
| 223 | Cancer Center of Kansas - Parsons | Parsons | Kansas | United States | 67357 |
| 224 | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas | United States | 66208 |
| 225 | Cancer Center of Kansas - Pratt | Pratt | Kansas | United States | 67124 |
| 226 | Cancer Center of Kansas - Salina | Salina | Kansas | United States | 67401 |
| 227 | Cancer Center of Kansas - Wellington | Wellington | Kansas | United States | 67152 |
| 228 | Associates In Womens Health | Wichita | Kansas | United States | 67208 |
| 229 | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 230 | Ascension Via Christi Hospitals Wichita | Wichita | Kansas | United States | 67214 |
| 231 | Cancer Center of Kansas - Wichita | Wichita | Kansas | United States | 67214 |
| 232 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 233 | Wichita NCI Community Oncology Research Program | Wichita | Kansas | United States | 67214 |
| 234 | Cancer Center of Kansas - Winfield | Winfield | Kansas | United States | 67156 |
| 235 | Flaget Memorial Hospital | Bardstown | Kentucky | United States | 40004 |
| 236 | Commonwealth Cancer Center-Corbin | Corbin | Kentucky | United States | 40701 |
| 237 | Oncology Hematology Care Inc-Crestview | Crestview Hills | Kentucky | United States | 41017 |
| 238 | Saint Joseph Radiation Oncology Resource Center | Lexington | Kentucky | United States | 40504 |
| 239 | Saint Joseph Hospital East | Lexington | Kentucky | United States | 40509 |
| 240 | Jewish Hospital | Louisville | Kentucky | United States | 40202 |
| 241 | The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | United States | 40202 |
| 242 | Saints Mary and Elizabeth Hospital | Louisville | Kentucky | United States | 40215 |
| 243 | UofL Health Medical Center Northeast | Louisville | Kentucky | United States | 40245 |
| 244 | Jewish Hospital Medical Center South | Shepherdsville | Kentucky | United States | 40165 |
| 245 | Baton Rouge General Medical Center | Baton Rouge | Louisiana | United States | 70806 |
| 246 | Hematology/Oncology Clinic PLLC | Baton Rouge | Louisiana | United States | 70809 |
| 247 | Woman's Hospital | Baton Rouge | Louisiana | United States | 70817 |
| 248 | West Jefferson Medical Center | Marrero | Louisiana | United States | 70072 |
| 249 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 250 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
| 251 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 252 | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland | United States | 21237 |
| 253 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
| 254 | Christiana Care - Union Hospital | Elkton | Maryland | United States | 21921 |
| 255 | Northwest Hospital Center | Randallstown | Maryland | United States | 21133 |
| 256 | UMass Memorial Medical Center - Memorial Division | Worcester | Massachusetts | United States | 01605 |
| 257 | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 258 | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | United States | 48106 |
| 259 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 260 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
| 261 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
| 262 | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | United States | 49307 |
| 263 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 264 | Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | United States | 48114 |
| 265 | Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | United States | 48183 |
| 266 | Saint Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 267 | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | United States | 48188 |
| 268 | Caro Cancer Center | Caro | Michigan | United States | 48723 |
| 269 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 270 | Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | United States | 48118 |
| 271 | Hematology Oncology Consultants-Clarkston | Clarkston | Michigan | United States | 48346 |
| 272 | Newland Medical Associates-Clarkston | Clarkston | Michigan | United States | 48346 |
| 273 | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | United States | 48038 |
| 274 | Beaumont Hospital - Dearborn | Dearborn | Michigan | United States | 48124 |
| 275 | Henry Ford Medical Center-Fairlane | Dearborn | Michigan | United States | 48126 |
| 276 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 277 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 278 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 279 | Great Lakes Cancer Management Specialists-Doctors Park | East China Township | Michigan | United States | 48054 |
| 280 | Green Bay Oncology - Escanaba | Escanaba | Michigan | United States | 49829 |
| 281 | Weisberg Cancer Treatment Center | Farmington Hills | Michigan | United States | 48334 |
| 282 | Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | United States | 48503 |
| 283 | Genesee Hematology Oncology PC | Flint | Michigan | United States | 48503 |
| 284 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 285 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 286 | Genesys Regional Medical Center | Grand Blanc | Michigan | United States | 48439 |
| 287 | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | United States | 49503 |
| 288 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
| 289 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 290 | Academic Hematology Oncology Specialists | Grosse Pointe Woods | Michigan | United States | 48236 |
| 291 | Great Lakes Cancer Management Specialists-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan | United States | 48236 |
| 292 | Michigan Breast Specialists-Grosse Pointe Woods | Grosse Pointe Woods | Michigan | United States | 48236 |
| 293 | Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan | United States | 49801 |
| 294 | Allegiance Health | Jackson | Michigan | United States | 49201 |
| 295 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 296 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 297 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49048 |
| 298 | Sparrow Hospital | Lansing | Michigan | United States | 48912 |
| 299 | Hope Cancer Clinic | Livonia | Michigan | United States | 48154 |
| 300 | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | United States | 48154 |
| 301 | Great Lakes Cancer Management Specialists-Macomb Medical Campus | Macomb | Michigan | United States | 48044 |
| 302 | Michigan Breast Specialists-Macomb Township | Macomb | Michigan | United States | 48044 |
| 303 | Saint Mary's Oncology/Hematology Associates of Marlette | Marlette | Michigan | United States | 48453 |
| 304 | Mercy Health Partners-Hackley Campus | Muskegon | Michigan | United States | 49442 |
| 305 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
| 306 | Lakeland Hospital Niles | Niles | Michigan | United States | 49120 |
| 307 | Henry Ford Medical Center-Columbus | Novi | Michigan | United States | 48377 |
| 308 | McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | United States | 49770 |
| 309 | 21st Century Oncology-Pontiac | Pontiac | Michigan | United States | 48341 |
| 310 | Hope Cancer Center | Pontiac | Michigan | United States | 48341 |
| 311 | Newland Medical Associates-Pontiac | Pontiac | Michigan | United States | 48341 |
| 312 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
| 313 | Lake Huron Medical Center | Port Huron | Michigan | United States | 48060 |
| 314 | Spectrum Health Reed City Hospital | Reed City | Michigan | United States | 49677 |
| 315 | Great Lakes Cancer Management Specialists-Rochester Hills | Rochester Hills | Michigan | United States | 48309 |
| 316 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 317 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
| 318 | Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan | United States | 48604 |
| 319 | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | United States | 49085 |
| 320 | Marie Yeager Cancer Center | Saint Joseph | Michigan | United States | 49085 |
| 321 | Bhadresh Nayak MD PC-Sterling Heights | Sterling Heights | Michigan | United States | 48312 |
| 322 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 323 | Advanced Breast Care Center PLLC | Warren | Michigan | United States | 48088 |
| 324 | Great Lakes Cancer Management Specialists-Macomb Professional Building | Warren | Michigan | United States | 48093 |
| 325 | Macomb Hematology Oncology PC | Warren | Michigan | United States | 48093 |
| 326 | Michigan Breast Specialists-Warren | Warren | Michigan | United States | 48093 |
| 327 | Saint John Macomb-Oakland Hospital | Warren | Michigan | United States | 48093 |
| 328 | Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | United States | 48322 |
| 329 | Saint Mary's Oncology/Hematology Associates of West Branch | West Branch | Michigan | United States | 48661 |
| 330 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 331 | Huron Gastroenterology PC | Ypsilanti | Michigan | United States | 48106 |
| 332 | Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | United States | 48197 |
| 333 | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | United States | 56601 |
| 334 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 335 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 336 | Saint Luke's Hospital of Duluth | Duluth | Minnesota | United States | 55805 |
| 337 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 338 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 339 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
| 340 | Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota | United States | 55369 |
| 341 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
| 342 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
| 343 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 344 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 345 | Health Partners Inc | Minneapolis | Minnesota | United States | 55454 |
| 346 | New Ulm Medical Center | New Ulm | Minnesota | United States | 56073 |
| 347 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
| 348 | Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | United States | 55416 |
| 349 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 350 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 351 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 352 | Saint Francis Regional Medical Center | Shakopee | Minnesota | United States | 55379 |
| 353 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
| 354 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 355 | Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
| 356 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
| 357 | Fairview Lakes Medical Center | Wyoming | Minnesota | United States | 55092 |
| 358 | Saint Dominic-Jackson Memorial Hospital | Jackson | Mississippi | United States | 39216 |
| 359 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 360 | Singing River Hospital | Pascagoula | Mississippi | United States | 39581 |
| 361 | Central Care Cancer Center - Bolivar | Bolivar | Missouri | United States | 65613 |
| 362 | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | United States | 63628 |
| 363 | Cox Cancer Center Branson | Branson | Missouri | United States | 65616 |
| 364 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 365 | Southeast Cancer Center | Cape Girardeau | Missouri | United States | 63703 |
| 366 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
| 367 | Centerpoint Medical Center LLC | Independence | Missouri | United States | 64057 |
| 368 | Capital Region Southwest Campus | Jefferson City | Missouri | United States | 65109 |
| 369 | Freeman Health System | Joplin | Missouri | United States | 64804 |
| 370 | Mercy Hospital Joplin | Joplin | Missouri | United States | 64804 |
| 371 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
| 372 | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri | United States | 64118 |
| 373 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
| 374 | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | United States | 64086 |
| 375 | Liberty Radiation Oncology Center | Liberty | Missouri | United States | 64068 |
| 376 | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | United States | 65401 |
| 377 | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | United States | 65401 |
| 378 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
| 379 | SSM Health Saint Louis University Hospital | Saint Louis | Missouri | United States | 63104 |
| 380 | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri | United States | 63109 |
| 381 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 382 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 383 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 384 | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | United States | 63670 |
| 385 | Cancer Research for the Ozarks NCORP | Springfield | Missouri | United States | 65804 |
| 386 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
| 387 | CoxHealth South Hospital | Springfield | Missouri | United States | 65807 |
| 388 | Missouri Baptist Sullivan Hospital | Sullivan | Missouri | United States | 63080 |
| 389 | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | United States | 63127 |
| 390 | Saint Patrick Hospital - Community Hospital | Missoula | Montana | United States | 59802 |
| 391 | CHI Health Saint Francis | Grand Island | Nebraska | United States | 68803 |
| 392 | Heartland Hematology and Oncology | Kearney | Nebraska | United States | 68845 |
| 393 | CHI Health Good Samaritan | Kearney | Nebraska | United States | 68847 |
| 394 | Saint Elizabeth Regional Medical Center | Lincoln | Nebraska | United States | 68510 |
| 395 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
| 396 | Alegent Health Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
| 397 | Hematology and Oncology Consultants PC | Omaha | Nebraska | United States | 68122 |
| 398 | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
| 399 | Alegent Health Lakeside Hospital | Omaha | Nebraska | United States | 68130 |
| 400 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
| 401 | Midlands Community Hospital | Papillion | Nebraska | United States | 68046 |
| 402 | Women's Cancer Center of Nevada | Las Vegas | Nevada | United States | 89106 |
| 403 | Center of Hope at Renown Medical Center | Reno | Nevada | United States | 89502 |
| 404 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
| 405 | Cooper Hospital University Medical Center | Camden | New Jersey | United States | 08103 |
| 406 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 407 | The Cancer Institute of New Jersey Hamilton | Hamilton | New Jersey | United States | 08690 |
| 408 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 409 | Virtua Memorial | Mount Holly | New Jersey | United States | 08060 |
| 410 | Jersey Shore Medical Center | Neptune | New Jersey | United States | 07753 |
| 411 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 412 | Saint Luke's Hospital-Warren Campus | Phillipsburg | New Jersey | United States | 08865 |
| 413 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
| 414 | MD Anderson Cancer Center at Cooper-Voorhees | Voorhees | New Jersey | United States | 08043 |
| 415 | Virtua Voorhees | Voorhees | New Jersey | United States | 08043 |
| 416 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 417 | Southwest Gynecologic Oncology Associates Inc | Albuquerque | New Mexico | United States | 87106 |
| 418 | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | United States | 88011 |
| 419 | Women's Cancer Care Associates LLC | Albany | New York | United States | 12208 |
| 420 | Island Gynecologic Oncology | Brightwaters | New York | United States | 11718 |
| 421 | State University of New York Downstate Medical Center | Brooklyn | New York | United States | 11203 |
| 422 | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 423 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 424 | Northwell Health/Center for Advanced Medicine | Lake Success | New York | United States | 11042 |
| 425 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 426 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 427 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
| 428 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 429 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 430 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 431 | University of Rochester | Rochester | New York | United States | 14642 |
| 432 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 433 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 434 | Randolph Hospital | Asheboro | North Carolina | United States | 27203 |
| 435 | AdventHealth Infusion Center Asheville | Asheville | North Carolina | United States | 28803 |
| 436 | Cone Health Cancer Center at Alamance Regional | Burlington | North Carolina | United States | 27215 |
| 437 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 438 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 439 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
| 440 | Oncology Specialists of Charlotte | Charlotte | North Carolina | United States | 28207 |
| 441 | Southern Oncology Specialists-Charlotte | Charlotte | North Carolina | United States | 28262 |
| 442 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 443 | Cone Health Cancer Center | Greensboro | North Carolina | United States | 27403 |
| 444 | AdventHealth Hendersonville | Hendersonville | North Carolina | United States | 28792 |
| 445 | Novant Health Cancer Institute - Huntersville | Huntersville | North Carolina | United States | 28078 |
| 446 | Southern Oncology Specialists-Huntersville | Huntersville | North Carolina | United States | 28078 |
| 447 | Matthews Radiation Oncology Center | Matthews | North Carolina | United States | 28105 |
| 448 | Novant Health Cancer Institute - Matthews | Matthews | North Carolina | United States | 28105 |
| 449 | Cone Heath Cancer Center at Mebane | Mebane | North Carolina | United States | 27302 |
| 450 | Novant Health Cancer Institute - Mooresville | Mooresville | North Carolina | United States | 28117 |
| 451 | FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina | United States | 28374 |
| 452 | Duke Raleigh Hospital | Raleigh | North Carolina | United States | 27609 |
| 453 | Annie Penn Memorial Hospital | Reidsville | North Carolina | United States | 27320 |
| 454 | Southeast Clinical Oncology Research Consortium NCORP | Winston-Salem | North Carolina | United States | 27104 |
| 455 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 456 | Sanford Bismarck Medical Center | Bismarck | North Dakota | United States | 58501 |
| 457 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 458 | Sanford Clinic North-Fargo | Fargo | North Dakota | United States | 58122 |
| 459 | Sanford Roger Maris Cancer Center | Fargo | North Dakota | United States | 58122 |
| 460 | Summa Health System - Akron Campus | Akron | Ohio | United States | 44304 |
| 461 | Cleveland Clinic Akron General | Akron | Ohio | United States | 44307 |
| 462 | Strecker Cancer Center-Belpre | Belpre | Ohio | United States | 45714 |
| 463 | Aultman Health Foundation | Canton | Ohio | United States | 44710 |
| 464 | Dayton Physicians LLC-Miami Valley South | Centerville | Ohio | United States | 45459 |
| 465 | Miami Valley Hospital South | Centerville | Ohio | United States | 45459 |
| 466 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
| 467 | Oncology Hematology Care Inc-Eden Park | Cincinnati | Ohio | United States | 45202 |
| 468 | Oncology Hematology Care Inc-Mercy West | Cincinnati | Ohio | United States | 45211 |
| 469 | University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | United States | 45219 |
| 470 | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 471 | Oncology Hematology Care Inc-Anderson | Cincinnati | Ohio | United States | 45230 |
| 472 | Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio | United States | 45236 |
| 473 | Bethesda North Hospital | Cincinnati | Ohio | United States | 45242 |
| 474 | Oncology Hematology Care Inc-Blue Ash | Cincinnati | Ohio | United States | 45242 |
| 475 | TriHealth Cancer Institute-Westside | Cincinnati | Ohio | United States | 45247 |
| 476 | TriHealth Cancer Institute-Anderson | Cincinnati | Ohio | United States | 45255 |
| 477 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 478 | MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 479 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 480 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 481 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 482 | Mount Carmel East Hospital | Columbus | Ohio | United States | 43213 |
| 483 | Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | United States | 43214 |
| 484 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
| 485 | Columbus NCI Community Oncology Research Program | Columbus | Ohio | United States | 43215 |
| 486 | Grant Medical Center | Columbus | Ohio | United States | 43215 |
| 487 | The Mark H Zangmeister Center | Columbus | Ohio | United States | 43219 |
| 488 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
| 489 | Doctors Hospital | Columbus | Ohio | United States | 43228 |
| 490 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
| 491 | Good Samaritan Hospital - Dayton | Dayton | Ohio | United States | 45406 |
| 492 | Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
| 493 | Dayton Physician LLC-Miami Valley Hospital North | Dayton | Ohio | United States | 45415 |
| 494 | Miami Valley Hospital North | Dayton | Ohio | United States | 45415 |
| 495 | Dayton NCI Community Oncology Research Program | Dayton | Ohio | United States | 45459 |
| 496 | Delaware Health Center-Grady Cancer Center | Delaware | Ohio | United States | 43015 |
| 497 | Delaware Radiation Oncology | Delaware | Ohio | United States | 43015 |
| 498 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
| 499 | Oncology Hematology Care Inc-Healthplex | Fairfield | Ohio | United States | 45014 |
| 500 | Armes Family Cancer Center | Findlay | Ohio | United States | 45840 |
| 501 | Blanchard Valley Hospital | Findlay | Ohio | United States | 45840 |
| 502 | Orion Cancer Care | Findlay | Ohio | United States | 45840 |
| 503 | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | United States | 45005-1066 |
| 504 | Dayton Physicians LLC-Atrium | Franklin | Ohio | United States | 45005 |
| 505 | Dayton Physicians LLC-Wayne | Greenville | Ohio | United States | 45331 |
| 506 | Wayne Hospital | Greenville | Ohio | United States | 45331 |
| 507 | Greater Dayton Cancer Center | Kettering | Ohio | United States | 45409 |
| 508 | First Dayton Cancer Care | Kettering | Ohio | United States | 45420 |
| 509 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
| 510 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
| 511 | Lancaster Radiation Oncology | Lancaster | Ohio | United States | 43130 |
| 512 | OhioHealth Mansfield Hospital | Mansfield | Ohio | United States | 44903 |
| 513 | Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
| 514 | OhioHealth Marion General Hospital | Marion | Ohio | United States | 43302 |
| 515 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
| 516 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
| 517 | Dayton Physicians LLC-Signal Point | Middletown | Ohio | United States | 45042 |
| 518 | Knox Community Hospital | Mount Vernon | Ohio | United States | 43050 |
| 519 | Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
| 520 | Newark Radiation Oncology | Newark | Ohio | United States | 43055 |
| 521 | Southern Ohio Medical Center | Portsmouth | Ohio | United States | 45662 |
| 522 | Dayton Physicians LLC-Wilson | Sidney | Ohio | United States | 45365 |
| 523 | Springfield Regional Cancer Center | Springfield | Ohio | United States | 45504 |
| 524 | Springfield Regional Medical Center | Springfield | Ohio | United States | 45505 |
| 525 | Dayton Physicians LLC-Upper Valley | Troy | Ohio | United States | 45373 |
| 526 | Upper Valley Medical Center | Troy | Ohio | United States | 45373 |
| 527 | Saint Ann's Hospital | Westerville | Ohio | United States | 43081 |
| 528 | Wright-Patterson Medical Center | Wright-Patterson Air Force Base | Ohio | United States | 45433 |
| 529 | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | United States | 43701 |
| 530 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 531 | Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | United States | 74136 |
| 532 | Warren Clinic-Tulsa South | Tulsa | Oklahoma | United States | 74136 |
| 533 | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | United States | 74146 |
| 534 | Warren Clinic Oncology-Tulsa | Tulsa | Oklahoma | United States | 74146 |
| 535 | Saint Alphonsus Medical Center-Baker City | Baker City | Oregon | United States | 97814 |
| 536 | Saint Charles Health System | Bend | Oregon | United States | 97701 |
| 537 | Clackamas Radiation Oncology Center | Clackamas | Oregon | United States | 97015 |
| 538 | Providence Cancer Institute Clackamas Clinic | Clackamas | Oregon | United States | 97015 |
| 539 | Bay Area Hospital | Coos Bay | Oregon | United States | 97420 |
| 540 | Providence Milwaukie Hospital | Milwaukie | Oregon | United States | 97222 |
| 541 | Providence Newberg Medical Center | Newberg | Oregon | United States | 97132 |
| 542 | Saint Alphonsus Medical Center-Ontario | Ontario | Oregon | United States | 97914 |
| 543 | Providence Willamette Falls Medical Center | Oregon City | Oregon | United States | 97045 |
| 544 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
| 545 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 546 | Providence Saint Vincent Medical Center | Portland | Oregon | United States | 97225 |
| 547 | Compass Oncology Rose Quarter | Portland | Oregon | United States | 97227 |
| 548 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 549 | Jefferson Abington Hospital | Abington | Pennsylvania | United States | 19001 |
| 550 | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | United States | 18103 |
| 551 | Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania | United States | 18015 |
| 552 | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | United States | 18017 |
| 553 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 554 | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | United States | 18201 |
| 555 | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 556 | Armstrong Center for Medicine and Health | Kittanning | Pennsylvania | United States | 16201 |
| 557 | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 558 | Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 559 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 560 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 561 | West Penn Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 562 | Community Medical Center | Scranton | Pennsylvania | United States | 18510 |
| 563 | Geisinger Medical Group | State College | Pennsylvania | United States | 16801 |
| 564 | Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
| 565 | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 566 | Women and Infants Hospital | Providence | Rhode Island | United States | 02905 |
| 567 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 568 | Black Hills Obstetrics and Gynecology | Rapid City | South Dakota | United States | 57701 |
| 569 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
| 570 | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | United States | 57104 |
| 571 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
| 572 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 573 | Bristol Regional Medical Center | Bristol | Tennessee | United States | 37620 |
| 574 | Wellmont Medical Associates Oncology and Hematology-Bristol | Bristol | Tennessee | United States | 37620 |
| 575 | Memorial Hospital | Chattanooga | Tennessee | United States | 37404 |
| 576 | Pulmonary Medicine Center of Chattanooga-Hixson | Hixson | Tennessee | United States | 37343 |
| 577 | Wellmont Medical Associates Oncology and Hematology-Johnson City | Johnson City | Tennessee | United States | 37604 |
| 578 | Ballad Health Cancer Care - Kingsport | Kingsport | Tennessee | United States | 37660 |
| 579 | Wellmont Holston Valley Hospital and Medical Center | Kingsport | Tennessee | United States | 37660 |
| 580 | Memorial GYN Plus | Ooltewah | Tennessee | United States | 37363 |
| 581 | Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | United States | 79106 |
| 582 | The Don and Sybil Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 583 | Dell Seton Medical Center at The University of Texas | Austin | Texas | United States | 78701 |
| 584 | Saint Joseph Regional Cancer Center | Bryan | Texas | United States | 77802 |
| 585 | MD Anderson in The Woodlands | Conroe | Texas | United States | 77384 |
| 586 | Parkland Memorial Hospital | Dallas | Texas | United States | 75235 |
| 587 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 588 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
| 589 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
| 590 | Lyndon Baines Johnson General Hospital | Houston | Texas | United States | 77026-1967 |
| 591 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 592 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 593 | Memorial Hermann Texas Medical Center | Houston | Texas | United States | 77030 |
| 594 | Methodist Willowbrook Hospital | Houston | Texas | United States | 77070 |
| 595 | MD Anderson West Houston | Houston | Texas | United States | 77079 |
| 596 | MD Anderson League City | League City | Texas | United States | 77573 |
| 597 | MD Anderson in Sugar Land | Sugar Land | Texas | United States | 77478 |
| 598 | Houston Methodist Sugar Land Hospital | Sugar Land | Texas | United States | 77479 |
| 599 | American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah | United States | 84003 |
| 600 | McKay-Dee Hospital Center | Ogden | Utah | United States | 84403 |
| 601 | Utah Valley Regional Medical Center | Provo | Utah | United States | 84604 |
| 602 | Saint George Regional Medical Center | Saint George | Utah | United States | 84770 |
| 603 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
| 604 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 605 | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont | United States | 05602 |
| 606 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 607 | University of Vermont and State Agricultural College | Burlington | Vermont | United States | 05405 |
| 608 | Wellmont Medical Associates-Bristol | Bristol | Virginia | United States | 24201 |
| 609 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 610 | Southwest VA Regional Cancer Center | Norton | Virginia | United States | 24273 |
| 611 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 612 | Carilion Clinic Gynecological Oncology | Roanoke | Virginia | United States | 24016 |
| 613 | Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | United States | 98520 |
| 614 | Cancer Care Center at Island Hospital | Anacortes | Washington | United States | 98221 |
| 615 | Swedish Cancer Institute-Eastside Oncology Hematology | Bellevue | Washington | United States | 98005 |
| 616 | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | United States | 98225 |
| 617 | PeaceHealth Medical Group PC | Bellingham | Washington | United States | 98226 |
| 618 | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington | United States | 98310 |
| 619 | Harrison Medical Center | Bremerton | Washington | United States | 98310 |
| 620 | Highline Medical Center-Main Campus | Burien | Washington | United States | 98166 |
| 621 | Providence Regional Cancer System-Centralia | Centralia | Washington | United States | 98531 |
| 622 | Swedish Cancer Institute-Edmonds | Edmonds | Washington | United States | 98026 |
| 623 | Saint Elizabeth Hospital | Enumclaw | Washington | United States | 98022 |
| 624 | Providence Regional Cancer Partnership | Everett | Washington | United States | 98201 |
| 625 | Saint Francis Hospital | Federal Way | Washington | United States | 98003 |
| 626 | Swedish Cancer Institute-Issaquah | Issaquah | Washington | United States | 98029 |
| 627 | Kadlec Clinic Hematology and Oncology | Kennewick | Washington | United States | 99336 |
| 628 | Providence Regional Cancer System-Lacey | Lacey | Washington | United States | 98503 |
| 629 | Saint Clare Hospital | Lakewood | Washington | United States | 98499 |
| 630 | PeaceHealth Saint John Medical Center | Longview | Washington | United States | 98632 |
| 631 | Skagit Regional Health Cancer Care Center | Mount Vernon | Washington | United States | 98274 |
| 632 | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington | United States | 98370 |
| 633 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 634 | Minor and James Medical PLLC | Seattle | Washington | United States | 98104 |
| 635 | Pacific Gynecology Specialists | Seattle | Washington | United States | 98104 |
| 636 | Swedish Medical Center-Ballard Campus | Seattle | Washington | United States | 98107 |
| 637 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
| 638 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 639 | Kaiser Permanente Washington | Seattle | Washington | United States | 98112 |
| 640 | Swedish Medical Center-First Hill | Seattle | Washington | United States | 98122-4307 |
| 641 | Swedish Medical Center-Cherry Hill | Seattle | Washington | United States | 98122-5711 |
| 642 | University of Washington Medical Center - Northwest | Seattle | Washington | United States | 98133 |
| 643 | Women's Cancer Center of Seattle | Seattle | Washington | United States | 98133 |
| 644 | University of Washington Medical Center - Montlake | Seattle | Washington | United States | 98195 |
| 645 | Olympic Medical Cancer Care Center | Sequim | Washington | United States | 98384 |
| 646 | Providence Regional Cancer System-Shelton | Shelton | Washington | United States | 98584 |
| 647 | MultiCare Deaconess Cancer and Blood Specialty Center - Valley | Spokane Valley | Washington | United States | 99216 |
| 648 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
| 649 | MultiCare Deaconess Cancer and Blood Specialty Center - Downtown | Spokane | Washington | United States | 99204 |
| 650 | Cancer Care Northwest-Valley | Spokane | Washington | United States | 99216 |
| 651 | Cancer Care Northwest-North Spokane | Spokane | Washington | United States | 99218 |
| 652 | Evergreen Hematology and Oncology PS | Spokane | Washington | United States | 99218 |
| 653 | MultiCare Deaconess Cancer and Blood Specialty Center - North | Spokane | Washington | United States | 99218 |
| 654 | Franciscan Research Center-Northwest Medical Plaza | Tacoma | Washington | United States | 98405 |
| 655 | MultiCare Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 656 | Northwest Medical Specialties PLLC | Tacoma | Washington | United States | 98405 |
| 657 | Saint Joseph Medical Center | Tacoma | Washington | United States | 98405 |
| 658 | PeaceHealth Southwest Medical Center | Vancouver | Washington | United States | 98664 |
| 659 | Compass Oncology Vancouver | Vancouver | Washington | United States | 98684 |
| 660 | Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | United States | 99362 |
| 661 | Wenatchee Valley Hospital and Clinics | Wenatchee | Washington | United States | 98801 |
| 662 | Cancer Institutes of Washington PLLC | Yakima | Washington | United States | 98902 |
| 663 | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | United States | 98902 |
| 664 | Providence Regional Cancer System-Yelm | Yelm | Washington | United States | 98597 |
| 665 | Aurora Health Center-Fond du Lac | Fond Du Lac | Wisconsin | United States | 54937 |
| 666 | Aurora Cancer Care-Grafton | Grafton | Wisconsin | United States | 53024 |
| 667 | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | United States | 54301-3526 |
| 668 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 669 | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | United States | 54303 |
| 670 | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | United States | 54303 |
| 671 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 672 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 673 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53792 |
| 674 | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | United States | 54143 |
| 675 | Bay Area Medical Center | Marinette | Wisconsin | United States | 54143 |
| 676 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 677 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 678 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 679 | Cancer Center of Western Wisconsin | New Richmond | Wisconsin | United States | 54017 |
| 680 | Saint Vincent Hospital Cancer Center at Oconto Falls | Oconto Falls | Wisconsin | United States | 54154 |
| 681 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 682 | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | United States | 53081 |
| 683 | Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | United States | 54235-1495 |
| 684 | Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin | United States | 54235 |
| 685 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 686 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 687 | Aspirus Regional Cancer Center | Wausau | Wisconsin | United States | 54401 |
| 688 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
| 689 | Cheyenne Regional Medical Center-West | Cheyenne | Wyoming | United States | 82001 |
| 690 | Tohoku University School of Medicine | Sendai | Aoba-ku | Japan | 980-8574 |
| 691 | Kure National Hospital | Kure | Hiroshima | Japan | 737 |
| 692 | Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
| 693 | Iwate Medical University Hospital | Shiwa-gun | Iwate | Japan | 028-3695 |
| 694 | Kagoshima City Hospital | Kagoshima City | Kagoshima | Japan | 890-8760 |
| 695 | Niigata University Medical and Dental Hospital | Niigata City | Niigata | Japan | 951-8520 |
| 696 | Shizuoka Cancer Center | Shizuoka City | Suntou | Japan | 411-8777 |
| 697 | Keio University | Shinjuku-ku | Tokyo | Japan | 160-8582 |
| 698 | Hiroshima University Hospital | Hiroshima City | Japan | 734-8551 | |
| 699 | Shikoku Cancer Center | Matsuyama | Japan | 791-0280 | |
| 700 | National Kyushu Cancer Center | Minami-ku | Japan | 811 1395 | |
| 701 | Jikei University School of Medicine | Minato-ku, Tokyo | Japan | 105-8461 | |
| 702 | Kindai University | Osaka | Japan | 589 8511 | |
| 703 | Saitama Medical University International Medical Center | Saitama | Japan | 350-1298 | |
| 704 | National Cancer Center Hospital | Tokyo | Japan | 104 0045 | |
| 705 | Tottori University | Tottori | Japan | 680-8550 | |
| 706 | Keimyung University-Dongsan Medical Center | Dalseo-gu | Daegu | Korea, Republic of | 42601 |
| 707 | National Cancer Center-Korea | Goyang-si | Gyeonggi-do | Korea, Republic of | 410-769 |
| 708 | Samsung Medical Center | Seoul | Korea | Korea, Republic of | 135-710 |
| 709 | Catholic University of Korea-Seoul Saint Mary's Hospital | Seoul | Korea | Korea, Republic of | 137-040 |
| 710 | Seoul National University Bundang Hospital | Seongnam City | Kyeonggi-do | Korea, Republic of | 463-707 |
| 711 | Gachon University Gil Hospital | Incheon | Korea, Republic of | 405-760 | |
| 712 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 713 | Gangnam Severance Hospital | Seoul | Korea, Republic of | 06273 | |
| 714 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 | |
| 715 | Kyung Hee University Hospital at Gangdong | Seoul | Korea, Republic of | 134-727 | |
| 716 | Korea Cancer Center Hospital | Seoul | Korea, Republic of | 139-706 | |
| 717 | Ewha Woman's University | Seoul | Korea, Republic of | 158-710 | |
| 718 | Ajou University Hospital | Suwon | Korea, Republic of | 443-721 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
- NRG Oncology
Investigators
- Principal Investigator: Robert L Coleman, NRG Oncology
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00565851
Other Study ID Numbers:
- NCI-2009-00587
- NCI-2009-00587
- 09-0205
- GOG-0213
- CDR0000546714
- GOG-0213
- GOG-0213
- U10CA180868
- U10CA027469
First Posted:
Nov 30, 2007
Last Update Posted:
Aug 9, 2022
Last Verified:
Jul 1, 2022
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | At the beginning of the study participants could be randomized to chemotherapy. On August 29, 2011 randomization to chemotherapy ended and participants could only be randomized to surgery. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm I (no Surgery; Carboplatin and Paclitaxel) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm III (Surgery; Carboplatin and Paclitaxel) | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm V (no Surgery; Carboplatin and Gemcitabine) | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | Arm VII (Surgery; Carboplatin and Gemcitabine) | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. | Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. |
| Period Title: Surgical Assignment | ||||||||
| STARTED | 316 | 456 | 33 | 165 | 6 | 34 | 5 | 37 |
| Randomized - Yes Surgery | 0 | 0 | 33 | 165 | 0 | 0 | 5 | 37 |
| Randomized - no Surgery | 33 | 172 | 0 | 0 | 6 | 34 | 0 | 0 |
| Not Surgical Candidate | 283 | 284 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 313 | 454 | 31 | 154 | 6 | 34 | 5 | 35 |
| NOT COMPLETED | 3 | 2 | 2 | 11 | 0 | 0 | 0 | 2 |
| Period Title: Surgical Assignment | ||||||||
| STARTED | 316 | 456 | 33 | 165 | 6 | 34 | 5 | 37 |
| Randomized to Chemo | 310 | 311 | 27 | 26 | 0 | 0 | 0 | 0 |
| Pre-specified Chemo | 6 | 145 | 6 | 139 | 6 | 34 | 5 | 37 |
| COMPLETED | 307 | 433 | 30 | 129 | 6 | 31 | 5 | 34 |
| NOT COMPLETED | 9 | 23 | 3 | 36 | 0 | 3 | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | Arm I (no Surgery; Carboplatin and Paclitaxel) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm III (Surgery; Carboplatin and Paclitaxel) | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm V (no Surgery; Carboplatin and Gemcitabine) | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)) | Arm VII (Surgery; Carboplatin and Gemcitabine) | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | Total of all reporting groups |
| Overall Participants | 316 | 456 | 33 | 165 | 6 | 34 | 5 | 37 | 1052 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
60.9
(10.0)
|
59.0
(10.3)
|
58.7
(10.0)
|
57.1
(10.5)
|
72.1
(7.4)
|
58.7
(8.2)
|
60.7
(9.3)
|
61.1
(9.5)
|
59.4
(10.2)
|
| Age, Customized (Count of Participants) | |||||||||
| < 40 years |
4
1.3%
|
14
3.1%
|
0
0%
|
7
4.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
25
2.4%
|
| 40 - 49 years |
40
12.7%
|
68
14.9%
|
6
18.2%
|
37
22.4%
|
0
0%
|
6
17.6%
|
1
20%
|
6
16.2%
|
164
15.6%
|
| 50 - 59 years |
102
32.3%
|
170
37.3%
|
11
33.3%
|
57
34.5%
|
1
16.7%
|
14
41.2%
|
1
20%
|
9
24.3%
|
365
34.7%
|
| 60 - 69 years |
111
35.1%
|
143
31.4%
|
10
30.3%
|
44
26.7%
|
0
0%
|
12
35.3%
|
2
40%
|
13
35.1%
|
335
31.8%
|
| 70 - 79 years |
52
16.5%
|
54
11.8%
|
6
18.2%
|
19
11.5%
|
5
83.3%
|
2
5.9%
|
1
20%
|
9
24.3%
|
148
14.1%
|
| ≥ 80 years |
7
2.2%
|
7
1.5%
|
0
0%
|
1
0.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
15
1.4%
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
316
100%
|
456
100%
|
33
100%
|
165
100%
|
6
100%
|
34
100%
|
5
100%
|
37
100%
|
1052
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
14
4.4%
|
22
4.8%
|
0
0%
|
6
3.6%
|
0
0%
|
0
0%
|
0
0%
|
4
10.8%
|
46
4.4%
|
| Not Hispanic or Latino |
272
86.1%
|
409
89.7%
|
30
90.9%
|
155
93.9%
|
6
100%
|
34
100%
|
5
100%
|
32
86.5%
|
943
89.6%
|
| Unknown or Not Reported |
30
9.5%
|
25
5.5%
|
3
9.1%
|
4
2.4%
|
0
0%
|
0
0%
|
0
0%
|
1
2.7%
|
63
6%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||
| American Indian or Alaska Native |
1
0.3%
|
5
1.1%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
6
0.6%
|
| Asian |
39
12.3%
|
136
29.8%
|
6
18.2%
|
101
61.2%
|
0
0%
|
14
41.2%
|
1
20%
|
10
27%
|
307
29.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.1%
|
| Black or African American |
15
4.7%
|
17
3.7%
|
1
3%
|
4
2.4%
|
1
16.7%
|
3
8.8%
|
1
20%
|
2
5.4%
|
44
4.2%
|
| White |
255
80.7%
|
294
64.5%
|
26
78.8%
|
57
34.5%
|
5
83.3%
|
17
50%
|
3
60%
|
25
67.6%
|
682
64.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
6
1.9%
|
3
0.7%
|
0
0%
|
3
1.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
12
1.1%
|
| Region of Enrollment (Count of Participants) | |||||||||
| South Korea |
20
6.3%
|
108
23.7%
|
4
12.1%
|
90
54.5%
|
0
0%
|
11
32.4%
|
0
0%
|
9
24.3%
|
242
23%
|
| United States |
284
89.9%
|
324
71.1%
|
29
87.9%
|
67
40.6%
|
6
100%
|
23
67.6%
|
5
100%
|
28
75.7%
|
766
72.8%
|
| Japan |
12
3.8%
|
24
5.3%
|
0
0%
|
7
4.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
43
4.1%
|
| Russia |
0
0%
|
0
0%
|
0
0%
|
1
0.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.1%
|
| Histology (Count of Participants) | |||||||||
| Serous |
252
79.7%
|
383
84%
|
30
90.9%
|
142
86.1%
|
5
83.3%
|
30
88.2%
|
4
80%
|
35
94.6%
|
881
83.7%
|
| Endometrioid |
25
7.9%
|
24
5.3%
|
0
0%
|
9
5.5%
|
1
16.7%
|
2
5.9%
|
0
0%
|
2
5.4%
|
63
6%
|
| Clear Cell |
13
4.1%
|
14
3.1%
|
1
3%
|
5
3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
33
3.1%
|
| Mucinous |
2
0.6%
|
2
0.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
4
0.4%
|
| Other |
24
7.6%
|
33
7.2%
|
2
6.1%
|
9
5.5%
|
0
0%
|
2
5.9%
|
1
20%
|
0
0%
|
71
6.7%
|
Outcome Measures
| Title | To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer |
|---|---|
| Description | The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method. |
| Time Frame | The time frame is 82.5 months (median duration of follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol) |
| Arm/Group Title | No Cytoreductive Surgery | Cytoreductive Surgery |
|---|---|---|
| Arm/Group Description | All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis | All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis |
| Measure Participants | 245 | 240 |
| Median (95% Confidence Interval) [Months] |
64.7
|
50.6
|
| Title | To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer |
|---|---|
| Description | The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method. |
| Time Frame | The time frame is 82.5 months (median duration of follow-up). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). |
| Arm/Group Title | Paclitaxel and Carboplatin Chemotherapy | Paclitaxel and Carboplatin Chemotherapy With Bevacizumab |
|---|---|---|
| Arm/Group Description | All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis | All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis |
| Measure Participants | 337 | 337 |
| Median (95% Confidence Interval) [Months] |
37.3
|
42.2
|
| Title | Progression-free Survival (Chemotherapy Analysis) |
|---|---|
| Description | Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause. |
| Time Frame | Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who were enrolled and eligible for the chemotherapy analysis (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). |
| Arm/Group Title | Paclitaxel and Carboplatin Chemotherapy | Paclitaxel and Carboplatin Chemotherapy With Bevacizumab |
|---|---|---|
| Arm/Group Description | All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis | All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis |
| Measure Participants | 337 | 337 |
| Median (95% Confidence Interval) [Months] |
10.4
|
13.8
|
| Title | Progression Free Survival (Surgery Analysis) |
|---|---|
| Description | Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause. |
| Time Frame | Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol). |
| Arm/Group Title | No Cytoreductive Surgery | Cytoreductive Surgery |
|---|---|---|
| Arm/Group Description | All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis | All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis |
| Measure Participants | 245 | 240 |
| Median (95% Confidence Interval) [Months] |
16.2
|
18.9
|
| Title | Summary of Adverse Events (CTCAE Version 4.0) |
|---|---|
| Description | Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0)) |
| Time Frame | During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible and treated participants |
| Arm/Group Title | Arm I (no Surgery; Carboplatin and Paclitaxel) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm III (Surgery; Carboplatin and Paclitaxel) | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm V (no Surgery; Carboplatin and Gemcitabine) | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)) | Arm VII (Surgery; Carboplatin and Gemcitabine) | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)) |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Bevacizumab: Given IV Carboplatin: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies |
| Measure Participants | 316 | 456 | 33 | 165 | 6 | 34 | 5 | 37 |
| Count of Participants [Participants] |
304
96.2%
|
376
82.5%
|
29
87.9%
|
77
46.7%
|
3
50%
|
9
26.5%
|
3
60%
|
9
24.3%
|
| Title | Patient Reported Quality of Life (Chemotherapy Analysis) |
|---|---|
| Description | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL. |
| Time Frame | 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). |
| Arm/Group Title | Paclitaxel and Carboplatin Chemotherapy | Paclitaxel and Carboplatin Chemotherapy With Bevacizumab |
|---|---|---|
| Arm/Group Description | All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis | All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis |
| Measure Participants | 298 | 302 |
| Prior to cycle 1 (baseline) |
75.8
(0.8)
|
75.3
(0.9)
|
| Prior to cycle 3 |
74.2
(1.0)
|
73.4
(0.9)
|
| Prior to cycle 6 |
73.3
(1.0)
|
72.3
(1.0)
|
| 6 months post cycle 1 |
77.1
(1.0)
|
77.2
(1.0)
|
| 12 months post cycle 1 |
77.0
(1.1)
|
77.8
(1.0)
|
| Title | Patient Reported Physical Function (Chemotherapy Analysis) |
|---|---|
| Description | Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. |
| Time Frame | 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Provided baseline and at least one follow-up assessments (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol). |
| Arm/Group Title | Paclitaxel and Carboplatin Chemotherapy | Paclitaxel and Carboplatin Chemotherapy With Bevacizumab |
|---|---|---|
| Arm/Group Description | All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis | All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis |
| Measure Participants | 298 | 302 |
| Prior to cycle 1 (baseline) |
71.5
(1.6)
|
69.4
(1.7)
|
| Prior to cycle 3 |
73.2
(2.1)
|
69.8
(2.1)
|
| Prior to cycle 6 |
71.5
(2.2)
|
64.6
(2.2)
|
| 6 months post cycle 1 |
71.6
(2.2)
|
70.2
(2.1)
|
| 12 months post cycle 1 |
71.8
(2.2)
|
70.7
(2.2)
|
| Title | Patient Reported Quality of Life (Surgery Analysis) |
|---|---|
| Description | Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL. |
| Time Frame | 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol). |
| Arm/Group Title | No Cytoreductive Surgery | Cytoreductive Surgery |
|---|---|---|
| Arm/Group Description | All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis | All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis |
| Measure Participants | 215 | 206 |
| Prior to surgery |
74.5
(1.0)
|
74.2
(1.0)
|
| 6 weeks post-surgery |
69.3
(1.3)
|
68.4
(1.3)
|
| 15 weeks post-surgery |
68.7
(1.3)
|
68.8
(1.3)
|
| 6 months post-surgery |
72.6
(1.3)
|
73.5
(1.3)
|
| 12 months post-surgery |
74.0
(1.4)
|
75.6
(1.3)
|
| Title | Patient Reported Physical Functioning (Surgery Analysis) |
|---|---|
| Description | Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only. |
| Time Frame | 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| US patients who provided baseline and ≥ 1 follow-up assessments (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol). |
| Arm/Group Title | No Cytoreductive Surgery | Cytoreductive Surgery |
|---|---|---|
| Arm/Group Description | All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis | All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis |
| Measure Participants | 104 | 113 |
| Prior to surgery (baseline) |
73.4
(2.3)
|
71.7
(2.3)
|
| 6 weeks post-surgery |
73.2
(2.1)
|
69.8
(2.1)
|
| 15 weeks post-surgery |
71.5
(2.2)
|
64.6
(2.2)
|
| 6 months post-surgery |
71.6
(2.2)
|
70.2
(2.1)
|
| 12 months post-surgery |
71.8
(2.2)
|
70.7
(2.2)
|
Adverse Events
| Time Frame | During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy). | |||||||||||||||
| Arm/Group Title | Arm I (no Surgery; Carboplatin and Paclitaxel) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm III (Surgery; Carboplatin and Paclitaxel) | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm V (no Surgery; Carboplatin and Gemcitabine) | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | Arm VII (Surgery; Carboplatin and Gemcitabine) | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) | ||||||||
| Arm/Group Description | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. | Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. | Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. | Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. | ||||||||
All Cause Mortality |
||||||||||||||||
| Arm I (no Surgery; Carboplatin and Paclitaxel) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm III (Surgery; Carboplatin and Paclitaxel) | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm V (no Surgery; Carboplatin and Gemcitabine) | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | Arm VII (Surgery; Carboplatin and Gemcitabine) | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 253/316 (80.1%) | 299/456 (65.6%) | 28/33 (84.8%) | 56/165 (33.9%) | 4/6 (66.7%) | 14/34 (41.2%) | 4/5 (80%) | 21/37 (56.8%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Arm I (no Surgery; Carboplatin and Paclitaxel) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm III (Surgery; Carboplatin and Paclitaxel) | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm V (no Surgery; Carboplatin and Gemcitabine) | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | Arm VII (Surgery; Carboplatin and Gemcitabine) | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 37/316 (11.7%) | 104/456 (22.8%) | 1/33 (3%) | 24/165 (14.5%) | 0/6 (0%) | 1/34 (2.9%) | 2/5 (40%) | 2/37 (5.4%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Myelodysplasia | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neutrophils | 3/316 (0.9%) | 4/456 (0.9%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Platelets | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Blood/Bone Marrow - Other | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Leukocytes | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| S/N Arrhythmia: Atrial Fibrillation | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardiac Ischemia/Infarction | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypertension | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Lt Ventricular Systolic Dysfunction | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypotension | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardipulmonary Arrest | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| Blurred Vision | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Fistula, Gi - Colon/Cecum/Appendix | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Obstruction, Gi - Ileum | 2/316 (0.6%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Perforation, Gi - Colon | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Dental: Periodontal | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Fistula, Gi - Small Bowel Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Obstruction, Gi - Colon | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Perforation, Gi - Cecum | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ulcer,gi - Stomach | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ileus | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Obstruction, Gi - Small Bowel Nos | 1/316 (0.3%) | 6/456 (1.3%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Colitis | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Perforation, Gi - Small Bowel Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vomiting | 2/316 (0.6%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dehydration | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Constipation | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Nausea | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Diarrhea | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Death No Ctcae Term - Disease Progression Nos | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Death No Ctcae Term - Death Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Death No Ctcae Term - Sudden Death | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain - Other | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Chest /Thorax Nos | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Head/Headache | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Back | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Abdominal Pain Nos | 0/316 (0%) | 5/456 (1.1%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Hepatobiliary/Pancreas - Other | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Immune system disorders | ||||||||||||||||
| Allergic Reaction/Hypersensitivity | 1/316 (0.3%) | 8/456 (1.8%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Inf W/Gr 3 Or 4 Anc: Blood | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Foreign Body | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Blood | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Wound | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Febrile Neutropenia | 7/316 (2.2%) | 14/456 (3.1%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | 2/316 (0.6%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Infection - Other | 0/316 (0%) | 1/456 (0.2%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Sinus | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Liver | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Urinary Tract Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Foreign Body | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Catheter-Related | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Upper Airway Nos | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Eye Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Kidney | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Catheter-Related | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Cholesterol,serum High | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Alt | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hyponatremia | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hyperglycemia | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypokalemia | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Musculoskeletal/St: Other | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Muscle Weakness - Right-Sided | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| 2nd Mal: Poss. Related To Cancer Rx | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Syncope | 2/316 (0.6%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neurology - Other | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mood Alteration - Depression | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cns Ischemia | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Confusion | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Memory Impairment | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy-Sensory | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy-Motor | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Renal Failure | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| Vaginal Dryness | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Hypoxia | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dyspnea | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Ulceration | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Hemorrhage, Gi - Rectum | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Upper Gi Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage/Pulmonary - Nose | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Stomach | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Cns | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vascular - Other | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Thrombosis/Thrombus/Embolism | 4/316 (1.3%) | 6/456 (1.3%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Arm I (no Surgery; Carboplatin and Paclitaxel) | Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm III (Surgery; Carboplatin and Paclitaxel) | Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) | Arm V (no Surgery; Carboplatin and Gemcitabine) | Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) | Arm VII (Surgery; Carboplatin and Gemcitabine) | Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 304/316 (96.2%) | 376/456 (82.5%) | 29/33 (87.9%) | 77/165 (46.7%) | 3/6 (50%) | 9/34 (26.5%) | 3/5 (60%) | 9/37 (24.3%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Neutrophils | 282/316 (89.2%) | 363/456 (79.6%) | 28/33 (84.8%) | 72/165 (43.6%) | 3/6 (50%) | 7/34 (20.6%) | 3/5 (60%) | 8/37 (21.6%) | ||||||||
| Platelets | 173/316 (54.7%) | 264/456 (57.9%) | 22/33 (66.7%) | 52/165 (31.5%) | 3/6 (50%) | 7/34 (20.6%) | 3/5 (60%) | 8/37 (21.6%) | ||||||||
| Blood/Bone Marrow - Other | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Leukocytes | 276/316 (87.3%) | 350/456 (76.8%) | 28/33 (84.8%) | 67/165 (40.6%) | 3/6 (50%) | 9/34 (26.5%) | 3/5 (60%) | 9/37 (24.3%) | ||||||||
| Lymphopenia | 21/316 (6.6%) | 31/456 (6.8%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemoglobin | 279/316 (88.3%) | 316/456 (69.3%) | 29/33 (87.9%) | 67/165 (40.6%) | 3/6 (50%) | 9/34 (26.5%) | 3/5 (60%) | 9/37 (24.3%) | ||||||||
| Lymphedema-Related Fibrosis | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Lymphatics - Other | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Edema: Trunk/Genital | 1/316 (0.3%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Edema: Limb | 40/316 (12.7%) | 44/456 (9.6%) | 3/33 (9.1%) | 8/165 (4.8%) | 1/6 (16.7%) | 1/34 (2.9%) | 0/5 (0%) | 3/37 (8.1%) | ||||||||
| Edema: Head And Neck | 1/316 (0.3%) | 8/456 (1.8%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Prolonged Qtc Interval | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| S/N Arrhythmia: Atrial Fibrillation | 2/316 (0.6%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Palpitations | 12/316 (3.8%) | 19/456 (4.2%) | 1/33 (3%) | 4/165 (2.4%) | 1/6 (16.7%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Cardiac Arrhythmia - Other | 1/316 (0.3%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ventricular Arrhythmia - Tachycardia | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| S/N Arrhythmia: Sinus Tachycardia | 5/316 (1.6%) | 15/456 (3.3%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Supraventricular Tachycardia | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| S/N Arrhythmia: Sinus Bradycardia | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ventricular Arrhythmia - Pvcs | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ventricular Arrhythmia - Fibrillation | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardiac Ischemia/Infarction | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypertension | 10/316 (3.2%) | 147/456 (32.2%) | 0/33 (0%) | 22/165 (13.3%) | 0/6 (0%) | 1/34 (2.9%) | 1/5 (20%) | 5/37 (13.5%) | ||||||||
| Restrictive Cardiomyopathy | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Left Venticular Diastolic Dysfunction | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardiac General - Other | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardiac Troponin I (Ctni) | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypotension | 3/316 (0.9%) | 12/456 (2.6%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cardipulmonary Arrest | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Otitis Middle Ear | 1/316 (0.3%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Auditory/Ear - Other | 1/316 (0.3%) | 3/456 (0.7%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hearing (Without Monitoring Program) | 5/316 (1.6%) | 12/456 (2.6%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Tinnitus | 15/316 (4.7%) | 23/456 (5%) | 1/33 (3%) | 2/165 (1.2%) | 1/6 (16.7%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Hearing (Monitoring Program) | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Endocrine disorders | ||||||||||||||||
| Hot Flashes | 27/316 (8.5%) | 45/456 (9.9%) | 5/33 (15.2%) | 8/165 (4.8%) | 0/6 (0%) | 2/34 (5.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Diabetes | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Adh Secrection Abnormality | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypoparathyroidism | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Adrenal Insufficiency | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hyperthyroidism | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Endocrine - Other | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypothyroidism | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| Ocular/Visual - Other | 6/316 (1.9%) | 11/456 (2.4%) | 1/33 (3%) | 2/165 (1.2%) | 1/6 (16.7%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Scleral Necrosis | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Watery Eye | 7/316 (2.2%) | 7/456 (1.5%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dry Eye | 1/316 (0.3%) | 5/456 (1.1%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ocular Surface Disease | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cataract | 0/316 (0%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Photophobia | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Flashing Lights/Floaters | 6/316 (1.9%) | 19/456 (4.2%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Diplopia | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Blurred Vision | 36/316 (11.4%) | 55/456 (12.1%) | 2/33 (6.1%) | 4/165 (2.4%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Eyelid Dysfunction | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Proctitis | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Salivary Gland Changes | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Flatulence | 5/316 (1.6%) | 11/456 (2.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Ulcer,gi - Esophagus | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Perforation, Gi - Colon | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dental: Periodontal | 0/316 (0%) | 10/456 (2.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Fistula, Gi - Small Bowel Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Fistula, Gi - Rectum | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Gastritis | 4/316 (1.3%) | 5/456 (1.1%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Esophagitis | 2/316 (0.6%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Perforation, Gi - Cecum | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Hemorrhoids | 1/316 (0.3%) | 22/456 (4.8%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Heartburn | 28/316 (8.9%) | 51/456 (11.2%) | 3/33 (9.1%) | 8/165 (4.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mucositis (Functional/Sympt) - Esophagus | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ulcer,gi - Stomach | 0/316 (0%) | 5/456 (1.1%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dental: Teeth | 0/316 (0%) | 7/456 (1.5%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mucositis (Functional/Sympt) - Trachea | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ascites | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Leak, Gi - Rectum | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ileus | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Dysphagia | 6/316 (1.9%) | 20/456 (4.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Distention | 18/316 (5.7%) | 27/456 (5.9%) | 3/33 (9.1%) | 6/165 (3.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Taste Alteration | 36/316 (11.4%) | 46/456 (10.1%) | 3/33 (9.1%) | 10/165 (6.1%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Incontinence, Anal | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dry Mouth | 6/316 (1.9%) | 17/456 (3.7%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Mucositis (Functional/Sympt) - Stomach | 2/316 (0.6%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mucositis (Functional/Sympt) - Rectum | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mucositis (Functional/Sympt) - Oral Cavity | 32/316 (10.1%) | 69/456 (15.1%) | 2/33 (6.1%) | 8/165 (4.8%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Obstruction, Gi - Small Bowel Nos | 3/316 (0.9%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Fistula, Gi - Oral Cavity | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Colitis | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Perforation, Gi - Small Bowel Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mucositis (Clinical Exam) - Oral Cavity | 23/316 (7.3%) | 67/456 (14.7%) | 0/33 (0%) | 14/165 (8.5%) | 0/6 (0%) | 4/34 (11.8%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Mucositis (Clinical Exam) - Larynx | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vomiting | 75/316 (23.7%) | 125/456 (27.4%) | 7/33 (21.2%) | 16/165 (9.7%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 4/37 (10.8%) | ||||||||
| Anorexia | 78/316 (24.7%) | 129/456 (28.3%) | 10/33 (30.3%) | 19/165 (11.5%) | 0/6 (0%) | 3/34 (8.8%) | 1/5 (20%) | 1/37 (2.7%) | ||||||||
| Dehydration | 12/316 (3.8%) | 20/456 (4.4%) | 1/33 (3%) | 5/165 (3%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 1/37 (2.7%) | ||||||||
| Constipation | 167/316 (52.8%) | 193/456 (42.3%) | 20/33 (60.6%) | 39/165 (23.6%) | 2/6 (33.3%) | 2/34 (5.9%) | 1/5 (20%) | 3/37 (8.1%) | ||||||||
| Stricture, Gi - Stomach | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Nausea | 182/316 (57.6%) | 223/456 (48.9%) | 19/33 (57.6%) | 42/165 (25.5%) | 1/6 (16.7%) | 3/34 (8.8%) | 1/5 (20%) | 6/37 (16.2%) | ||||||||
| Gastrointestinal - Other | 3/316 (0.9%) | 10/456 (2.2%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Diarrhea | 98/316 (31%) | 148/456 (32.5%) | 11/33 (33.3%) | 30/165 (18.2%) | 0/6 (0%) | 3/34 (8.8%) | 0/5 (0%) | 4/37 (10.8%) | ||||||||
| Ulcer,gi - Small Bowel Nos | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mucositis (Clinical Exam) - Pharynx | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Constitutional Symptoms - Other | 0/316 (0%) | 5/456 (1.1%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Sweating | 10/316 (3.2%) | 8/456 (1.8%) | 2/33 (6.1%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Weight Gain | 18/316 (5.7%) | 27/456 (5.9%) | 1/33 (3%) | 6/165 (3.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Fever | 31/316 (9.8%) | 45/456 (9.9%) | 1/33 (3%) | 13/165 (7.9%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Weight Loss | 12/316 (3.8%) | 54/456 (11.8%) | 1/33 (3%) | 6/165 (3.6%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Rigors/Chills | 7/316 (2.2%) | 14/456 (3.1%) | 1/33 (3%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Fatigue | 245/316 (77.5%) | 297/456 (65.1%) | 25/33 (75.8%) | 48/165 (29.1%) | 2/6 (33.3%) | 5/34 (14.7%) | 3/5 (60%) | 5/37 (13.5%) | ||||||||
| Insomnia | 47/316 (14.9%) | 67/456 (14.7%) | 4/33 (12.1%) | 13/165 (7.9%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 3/37 (8.1%) | ||||||||
| Pain - Other | 6/316 (1.9%) | 22/456 (4.8%) | 2/33 (6.1%) | 3/165 (1.8%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Urethra | 3/316 (0.9%) | 3/456 (0.7%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Perineum | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Pelvis | 10/316 (3.2%) | 11/456 (2.4%) | 2/33 (6.1%) | 4/165 (2.4%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Breast | 4/316 (1.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Vagina | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Chest /Thorax Nos | 6/316 (1.9%) | 23/456 (5%) | 1/33 (3%) | 5/165 (3%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Pain: Chest Wall | 10/316 (3.2%) | 17/456 (3.7%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Throat/Pharynx/Larynx | 9/316 (2.8%) | 31/456 (6.8%) | 1/33 (3%) | 4/165 (2.4%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Pain: Pleura | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Larynx | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Eye | 0/316 (0%) | 6/456 (1.3%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Head/Headache | 59/316 (18.7%) | 142/456 (31.1%) | 7/33 (21.2%) | 19/165 (11.5%) | 2/6 (33.3%) | 4/34 (11.8%) | 1/5 (20%) | 2/37 (5.4%) | ||||||||
| Pain: Neck | 1/316 (0.3%) | 33/456 (7.2%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Pain: Extremity-Limb | 41/316 (13%) | 97/456 (21.3%) | 7/33 (21.2%) | 13/165 (7.9%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Pain: Buttock | 1/316 (0.3%) | 5/456 (1.1%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Back | 35/316 (11.1%) | 65/456 (14.3%) | 3/33 (9.1%) | 13/165 (7.9%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 2/37 (5.4%) | ||||||||
| Pain: Joint | 99/316 (31.3%) | 166/456 (36.4%) | 4/33 (12.1%) | 28/165 (17%) | 1/6 (16.7%) | 2/34 (5.9%) | 0/5 (0%) | 3/37 (8.1%) | ||||||||
| Pain: Bone | 19/316 (6%) | 33/456 (7.2%) | 3/33 (9.1%) | 8/165 (4.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Kidney | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Bladder | 1/316 (0.3%) | 4/456 (0.9%) | 2/33 (6.1%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Pain Nos | 4/316 (1.3%) | 8/456 (1.8%) | 0/33 (0%) | 7/165 (4.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Stomach | 3/316 (0.9%) | 9/456 (2%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Rectum | 1/316 (0.3%) | 6/456 (1.3%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Oral Cavity | 2/316 (0.6%) | 13/456 (2.9%) | 1/33 (3%) | 4/165 (2.4%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Esophagus | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Dental/Teeth/Peridontal | 0/316 (0%) | 9/456 (2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 2/37 (5.4%) | ||||||||
| Pain: Abdominal Pain Nos | 84/316 (26.6%) | 127/456 (27.9%) | 16/33 (48.5%) | 36/165 (21.8%) | 2/6 (33.3%) | 2/34 (5.9%) | 1/5 (20%) | 4/37 (10.8%) | ||||||||
| Pain: Scalp | 1/316 (0.3%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Oral - Gums | 0/316 (0%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Skin | 0/316 (0%) | 2/456 (0.4%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Lip | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Middle Ear | 5/316 (1.6%) | 8/456 (1.8%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Pain: External Ear | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Cardiac/ Heart | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Pain: Face | 0/316 (0%) | 6/456 (1.3%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Tumor | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Muscle | 55/316 (17.4%) | 107/456 (23.5%) | 4/33 (12.1%) | 23/165 (13.9%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Pain: Anus | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Neuralgia | 0/316 (0%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pain: Sinus | 0/316 (0%) | 6/456 (1.3%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Cytokine Release Syndrome | 4/316 (1.3%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Flu-Like Syndrome | 1/316 (0.3%) | 17/456 (3.7%) | 0/33 (0%) | 4/165 (2.4%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Hepatobiliary/Pancreas - Other | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cholecystitis | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Liver Dysfunction | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Immune system disorders | ||||||||||||||||
| Allergy/Immunology - Other | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Allergic Reaction/Hypersensitivity | 76/316 (24.1%) | 86/456 (18.9%) | 6/33 (18.2%) | 16/165 (9.7%) | 1/6 (16.7%) | 0/34 (0%) | 1/5 (20%) | 3/37 (8.1%) | ||||||||
| Vasculitis | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Rhinitis | 13/316 (4.1%) | 62/456 (13.6%) | 1/33 (3%) | 8/165 (4.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Autoimmune Reaction | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Inf W/Gr 3 Or 4 Anc: Blood | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) | 2/316 (0.6%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Middle Ear | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Vulva | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos | 10/316 (3.2%) | 20/456 (4.4%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Nose | 2/316 (0.6%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | 4/316 (1.3%) | 6/456 (1.3%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Larynx | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Meninges | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Brain | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Joint | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Blood | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Wound | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos | 2/316 (0.6%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | 6/316 (1.9%) | 7/456 (1.5%) | 1/33 (3%) | 1/165 (0.6%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related | 0/316 (0%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Febrile Neutropenia | 2/316 (0.6%) | 9/456 (2%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral | 0/316 (0%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Lung (Pneumonia) | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Nose | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Sinus | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth | 0/316 (0%) | 7/456 (1.5%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Colon | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | 19/316 (6%) | 25/456 (5.5%) | 3/33 (9.1%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Stomach | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Infection - Other | 7/316 (2.2%) | 14/456 (3.1%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Bladder (Urinary) | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia | 2/316 (0.6%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Colitis, Infectious (Eg.C. Difficile) | 1/316 (0.3%) | 4/456 (0.9%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus | 5/316 (1.6%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Appendix | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Inf Unknown Anc: Upper Airway Nos | 0/316 (0%) | 7/456 (1.5%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Vagina | 0/316 (0%) | 10/456 (2.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Sinus | 5/316 (1.6%) | 20/456 (4.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Pharynx | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Bronchus | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Eye Nos | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Soft Tissue Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Urinary Tract Nos | 6/316 (1.9%) | 10/456 (2.2%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Bladder (Urinary) | 2/316 (0.6%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Catheter-Related | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Inf Unknown Anc: Oral Cavity-Gums | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Dental-Tooth | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Abdomen Nos | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Skin (Cellulitis) | 1/316 (0.3%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf Unknown Anc: Middle Ear | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Vulva | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Vagina | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Upper Airway Nos | 4/316 (1.3%) | 6/456 (1.3%) | 0/33 (0%) | 4/165 (2.4%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Sinus | 1/316 (0.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Pharynx | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Nose | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) | 2/316 (0.6%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Bronchus | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Joint | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | 3/316 (0.9%) | 8/456 (1.8%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos | 6/316 (1.9%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Inf W/Nml Or Gr 1 Or 2 Anc: External Ear | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Ast | 30/316 (9.5%) | 62/456 (13.6%) | 2/33 (6.1%) | 6/165 (3.6%) | 0/6 (0%) | 2/34 (5.9%) | 1/5 (20%) | 3/37 (8.1%) | ||||||||
| Gfr | 2/316 (0.6%) | 7/456 (1.5%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Metabolic/Laboratory - Other | 10/316 (3.2%) | 14/456 (3.1%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cholesterol,serum High | 2/316 (0.6%) | 17/456 (3.7%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Proteinuria | 3/316 (0.9%) | 70/456 (15.4%) | 0/33 (0%) | 17/165 (10.3%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Creatinine | 17/316 (5.4%) | 52/456 (11.4%) | 1/33 (3%) | 5/165 (3%) | 0/6 (0%) | 2/34 (5.9%) | 2/5 (40%) | 1/37 (2.7%) | ||||||||
| Hypoalbuminemia | 20/316 (6.3%) | 43/456 (9.4%) | 1/33 (3%) | 4/165 (2.4%) | 0/6 (0%) | 3/34 (8.8%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Ggt | 2/316 (0.6%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Alt | 27/316 (8.5%) | 41/456 (9%) | 1/33 (3%) | 5/165 (3%) | 0/6 (0%) | 0/34 (0%) | 2/5 (40%) | 3/37 (8.1%) | ||||||||
| Alkaline Phosphatase | 22/316 (7%) | 35/456 (7.7%) | 2/33 (6.1%) | 1/165 (0.6%) | 0/6 (0%) | 1/34 (2.9%) | 1/5 (20%) | 3/37 (8.1%) | ||||||||
| Bilirubin | 3/316 (0.9%) | 12/456 (2.6%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Lipase | 1/316 (0.3%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypermagnesemia | 1/316 (0.3%) | 13/456 (2.9%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypophosphatemia | 13/316 (4.1%) | 22/456 (4.8%) | 3/33 (9.1%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hyponatremia | 19/316 (6%) | 60/456 (13.2%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 1/34 (2.9%) | 1/5 (20%) | 2/37 (5.4%) | ||||||||
| Hyperuricemia | 0/316 (0%) | 5/456 (1.1%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypertriglyceridemia | 3/316 (0.9%) | 11/456 (2.4%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Cpk | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Bicarbonate, Serum-Low | 3/316 (0.9%) | 7/456 (1.5%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Amylase | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypernatremia | 5/316 (1.6%) | 5/456 (1.1%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Hypocalcemia | 16/316 (5.1%) | 48/456 (10.5%) | 1/33 (3%) | 6/165 (3.6%) | 0/6 (0%) | 2/34 (5.9%) | 1/5 (20%) | 1/37 (2.7%) | ||||||||
| Hyperkalemia | 10/316 (3.2%) | 26/456 (5.7%) | 0/33 (0%) | 8/165 (4.8%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 1/37 (2.7%) | ||||||||
| Hyperglycemia | 74/316 (23.4%) | 111/456 (24.3%) | 5/33 (15.2%) | 10/165 (6.1%) | 1/6 (16.7%) | 3/34 (8.8%) | 2/5 (40%) | 2/37 (5.4%) | ||||||||
| Hypokalemia | 33/316 (10.4%) | 48/456 (10.5%) | 3/33 (9.1%) | 7/165 (4.2%) | 0/6 (0%) | 2/34 (5.9%) | 1/5 (20%) | 1/37 (2.7%) | ||||||||
| Hypoglycemia | 7/316 (2.2%) | 21/456 (4.6%) | 1/33 (3%) | 3/165 (1.8%) | 0/6 (0%) | 2/34 (5.9%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Hypercalcemia | 6/316 (1.9%) | 20/456 (4.4%) | 0/33 (0%) | 5/165 (3%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hypomagnesemia | 51/316 (16.1%) | 104/456 (22.8%) | 8/33 (24.2%) | 13/165 (7.9%) | 0/6 (0%) | 1/34 (2.9%) | 1/5 (20%) | 1/37 (2.7%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Musculoskeletal/St: Other | 1/316 (0.3%) | 11/456 (2.4%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 2/34 (5.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Soft Tissue Necrosis - Abdomen | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Osteoporosis | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Joint-Function | 2/316 (0.6%) | 4/456 (0.9%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Joint Effusion | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Fracture | 1/316 (0.3%) | 2/456 (0.4%) | 1/33 (3%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Extremity-Upper (Function) | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Gait/Walking | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cervical Spine Rom | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Arthritis | 3/316 (0.9%) | 20/456 (4.4%) | 1/33 (3%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Muscle Weakness - Whole Body/Generalized | 15/316 (4.7%) | 32/456 (7%) | 4/33 (12.1%) | 6/165 (3.6%) | 0/6 (0%) | 2/34 (5.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Muscle Weakness - Right-Sided | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Muscle Weakness - Left-Sided | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Muscle Weakness - Extremity-Upper | 1/316 (0.3%) | 3/456 (0.7%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Muscle Weakness - Extremity-Lower | 8/316 (2.5%) | 15/456 (3.3%) | 4/33 (12.1%) | 2/165 (1.2%) | 0/6 (0%) | 2/34 (5.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| 2nd Mal: Poss. Related To Cancer Rx | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Syncope | 3/316 (0.9%) | 8/456 (1.8%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Involuntary Movement | 5/316 (1.6%) | 2/456 (0.4%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neurology - Other | 1/316 (0.3%) | 5/456 (1.1%) | 0/33 (0%) | 0/165 (0%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mental Status | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Encephalopathy | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Mood Alteration - Depression | 42/316 (13.3%) | 51/456 (11.2%) | 5/33 (15.2%) | 12/165 (7.3%) | 1/6 (16.7%) | 1/34 (2.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Mood Alteration - Anxiety | 39/316 (12.3%) | 57/456 (12.5%) | 3/33 (9.1%) | 13/165 (7.9%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Mood Alteration - Agitation | 4/316 (1.3%) | 1/456 (0.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Tremor | 4/316 (1.3%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Speech Impairment | 0/316 (0%) | 5/456 (1.1%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Seizure | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Irritability | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Somnolence | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cognitive Disturbance | 1/316 (0.3%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cns Ischemia | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ataxia | 2/316 (0.6%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Confusion | 1/316 (0.3%) | 6/456 (1.3%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Memory Impairment | 7/316 (2.2%) | 16/456 (3.5%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dizziness | 24/316 (7.6%) | 51/456 (11.2%) | 4/33 (12.1%) | 8/165 (4.8%) | 1/6 (16.7%) | 2/34 (5.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy,cranial - Cn Xii Motor-Tongue | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy,cranial - Cn Viii Hearing/Balance | 2/316 (0.6%) | 1/456 (0.2%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy,cranial - Cn Vii Motor-Face | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy,cranial - Cn Iii Pupil | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy,cranial - Cn I Smell | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Neuropathy-Sensory | 237/316 (75%) | 272/456 (59.6%) | 18/33 (54.5%) | 55/165 (33.3%) | 3/6 (50%) | 4/34 (11.8%) | 1/5 (20%) | 5/37 (13.5%) | ||||||||
| Neuropathy-Motor | 15/316 (4.7%) | 14/456 (3.1%) | 2/33 (6.1%) | 5/165 (3%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Renal/Genitourinary - Other | 2/316 (0.6%) | 10/456 (2.2%) | 1/33 (3%) | 0/165 (0%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cystitis | 0/316 (0%) | 10/456 (2.2%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Urinary Color Change | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Urinary Retention | 2/316 (0.6%) | 6/456 (1.3%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Obstruction, Gu - Urethra | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Obstruction, Gu - Ureter | 3/316 (0.9%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Incontinence, Urinary | 16/316 (5.1%) | 20/456 (4.4%) | 1/33 (3%) | 3/165 (1.8%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Bladder Spasm | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Renal Failure | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Urinary Frequency | 25/316 (7.9%) | 35/456 (7.7%) | 3/33 (9.1%) | 4/165 (2.4%) | 1/6 (16.7%) | 1/34 (2.9%) | 1/5 (20%) | 0/37 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| Libido | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vaginal Dryness | 4/316 (1.3%) | 7/456 (1.5%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Sexual/Reproductive Function: Other | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vaginitis | 2/316 (0.6%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vaginal Discharge | 4/316 (1.3%) | 10/456 (2.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Pulmonary: Other | 3/316 (0.9%) | 10/456 (2.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Airway Obstruction - Larynx | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Airway Obstruction - Bronchus | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Nasal/Paranasal Reactions | 8/316 (2.5%) | 50/456 (11%) | 1/33 (3%) | 7/165 (4.2%) | 1/6 (16.7%) | 1/34 (2.9%) | 0/5 (0%) | 2/37 (5.4%) | ||||||||
| Edema, Larynx | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Bronchospasm | 3/316 (0.9%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Aspiration | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Voice Changes | 6/316 (1.9%) | 55/456 (12.1%) | 0/33 (0%) | 8/165 (4.8%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cough | 53/316 (16.8%) | 110/456 (24.1%) | 5/33 (15.2%) | 14/165 (8.5%) | 1/6 (16.7%) | 2/34 (5.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Pneumonitis | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pleural Effusion | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dyspnea | 80/316 (25.3%) | 110/456 (24.1%) | 4/33 (12.1%) | 15/165 (9.1%) | 2/6 (33.3%) | 1/34 (2.9%) | 1/5 (20%) | 2/37 (5.4%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Nail Changes | 9/316 (2.8%) | 39/456 (8.6%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Injection Site Reaction | 3/316 (0.9%) | 9/456 (2%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hair Loss/Alopecia (Scalp Or Body) | 245/316 (77.5%) | 289/456 (63.4%) | 21/33 (63.6%) | 47/165 (28.5%) | 2/6 (33.3%) | 3/34 (8.8%) | 1/5 (20%) | 2/37 (5.4%) | ||||||||
| Erythema Multiforme | 1/316 (0.3%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Cheilitis | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Wound Complication, Non-Infectious | 0/316 (0%) | 8/456 (1.8%) | 2/33 (6.1%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 1/5 (20%) | 1/37 (2.7%) | ||||||||
| Bruising | 11/316 (3.5%) | 15/456 (3.3%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Acne | 2/316 (0.6%) | 9/456 (2%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Rash | 49/316 (15.5%) | 87/456 (19.1%) | 4/33 (12.1%) | 10/165 (6.1%) | 0/6 (0%) | 3/34 (8.8%) | 1/5 (20%) | 2/37 (5.4%) | ||||||||
| Dry Skin | 5/316 (1.6%) | 25/456 (5.5%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Decubitus | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Telangiectasia | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Pruritus | 25/316 (7.9%) | 46/456 (10.1%) | 2/33 (6.1%) | 10/165 (6.1%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Burn | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Urticaria | 5/316 (1.6%) | 23/456 (5%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Flushing | 11/316 (3.5%) | 21/456 (4.6%) | 1/33 (3%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hand-Foot | 2/316 (0.6%) | 5/456 (1.1%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dermatology/Skin - Other | 10/316 (3.2%) | 23/456 (5%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hyperpigmentation | 1/316 (0.3%) | 10/456 (2.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ulceration | 1/316 (0.3%) | 9/456 (2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 1/37 (2.7%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Inr | 1/316 (0.3%) | 9/456 (2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Dic | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Thrombotic Microangiopathy | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Ptt | 1/316 (0.3%) | 7/456 (1.5%) | 1/33 (3%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gu - Urinary Nos | 0/316 (0%) | 5/456 (1.1%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gu - Vagina | 8/316 (2.5%) | 9/456 (2%) | 1/33 (3%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gu - Urethra | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage/Pulmonary - Lung | 1/316 (0.3%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Rectum | 6/316 (1.9%) | 19/456 (4.2%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage/Pulmonary - Respiratory Tract Nos | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Stoma | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Varices (Rectal) | 1/316 (0.3%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage/Pulmonary - Nose | 8/316 (2.5%) | 116/456 (25.4%) | 0/33 (0%) | 13/165 (7.9%) | 0/6 (0%) | 3/34 (8.8%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hematoma | 1/316 (0.3%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Anus | 0/316 (0%) | 6/456 (1.3%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gu - Ureter | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Lower Gi Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Oral Cavity | 2/316 (0.6%) | 17/456 (3.7%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gu - Bladder | 1/316 (0.3%) | 2/456 (0.4%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Stomach | 1/316 (0.3%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage, Gi - Colon | 0/316 (0%) | 3/456 (0.7%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Petechiae | 0/316 (0%) | 4/456 (0.9%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Hemorrhage/Bleeding - Other | 1/316 (0.3%) | 3/456 (0.7%) | 0/33 (0%) | 3/165 (1.8%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vascular - Other | 0/316 (0%) | 2/456 (0.4%) | 0/33 (0%) | 1/165 (0.6%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Visceral Arterial Ischemia | 0/316 (0%) | 0/456 (0%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Vein Injury - Extremity-Lower | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Artery Injury - Other Nos | 0/316 (0%) | 1/456 (0.2%) | 0/33 (0%) | 0/165 (0%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Thrombosis/Embolism (Vascular Access-Related) | 1/316 (0.3%) | 3/456 (0.7%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 1/34 (2.9%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Thrombosis/Thrombus/Embolism | 0/316 (0%) | 11/456 (2.4%) | 0/33 (0%) | 2/165 (1.2%) | 0/6 (0%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
| Phlebitis | 1/316 (0.3%) | 5/456 (1.1%) | 0/33 (0%) | 1/165 (0.6%) | 1/6 (16.7%) | 0/34 (0%) | 0/5 (0%) | 0/37 (0%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Christopher Purdy on behalf of Austin Miller PhD |
|---|---|
| Organization | NRG Oncology |
| Phone | (716) 845-1300 ext 2296 |
| purdyc@nrgoncology.org |
Responsible Party:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00565851
Other Study ID Numbers:
- NCI-2009-00587
- NCI-2009-00587
- 09-0205
- GOG-0213
- CDR0000546714
- GOG-0213
- GOG-0213
- U10CA180868
- U10CA027469
First Posted:
Nov 30, 2007
Last Update Posted:
Aug 9, 2022
Last Verified:
Jul 1, 2022