Trial Outcomes & Findings for Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer (NCT NCT00048893)
NCT ID: NCT00048893
Last Updated: 2012-04-13
Results Overview
Complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is a decrease of greater than or equal to 50% in the sum of the products of the longest perpendicular dimensions of all measurable target lesions. Stable disease (SD) is any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions of measurable disease. Progressive disease (PD) is a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease.
TERMINATED
PHASE1/PHASE2
37 participants
time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study
2012-04-13
Participant Flow
Participant milestones
| Measure |
Carcinoembryonic Antigen (CEA)-Tricom Vaccines
(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10\^8 plaque-forming unit (pfu) x 1 dose subcutaneously
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Carcinoembryonic Antigen (CEA)-Tricom Vaccines
n=37 Participants
(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10\^8 plaque-forming unit (pfu) x 1 dose subcutaneously
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
52 years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off studyPopulation: The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
Complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is a decrease of greater than or equal to 50% in the sum of the products of the longest perpendicular dimensions of all measurable target lesions. Stable disease (SD) is any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions of measurable disease. Progressive disease (PD) is a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 91 monthsHere are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Carcinoembryonic Antigen (CEA)-Tricom Vaccines
n=37 Participants
(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10\^8 plaque-forming unit (pfu) x 1 dose subcutaneously
|
|---|---|
|
Number of Participants With Adverse Events
|
11 Participants
|
SECONDARY outcome
Timeframe: time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off studyPopulation: The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
The log change in CEA-specific T cell precursor frequency will be calculated between values obtained at baseline and 5 months post immune depletion. A change equal to 1.0 standard deviation (SD) of the log change is significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 5 months post immune depletionPopulation: The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
Response is evaluated by CD4 response to CEA soluble protein. The log change in precursor frequencies will be calculated between values obtained at baseline and five months post immune depletion. By flow cytometry of peripheral blood lymphocyte frequency of potential killer cells directed to the CEA protein.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
It is expected that delayed administration of a vaccine will result in enhancement of immune response to the vaccine in those patients with later recovery of thymic function as evidenced by change in lymphocyte subsets in the blood.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After the immune depletion cyclePopulation: The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
The time period a participant remains free from progressive disease. Progressive disease (PD) is defined as a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease or the appearance of new disease or an increase in evaluable disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks, than 6, 12, 18, 24, 30, 36 (3y), 42, 48 (4y), 60 and 72 months after completion of immune chemotherapyPopulation: The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
Patients showing disease progression or recurrence at any point after the start of the early immunizations series may continue on study in accordance to the off study criteria and will be receiving monthly rF immunizations for a total of 12 months or until further disease progression meets the off study criteria. Immune response as evidenced by change in lymphocyte subsets in the blood.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the beginning of each cycle of chemotherapy (every 4 weeks)Population: The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
Defined as measurable disease (any solid lesion that can be measured accurately in at least one dimension), evaluable disease (disease not readily measurable but can be clinically assessed), complete response (complete disappearance of all measurable and evaluable disease), partial response (decrease of greater than or equal to 50%), stable disease (any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions), or progressive disease (greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease).
Outcome measures
Outcome data not reported
Adverse Events
Carcinoembryonic Antigen (CEA)-Tricom Vaccines
Serious adverse events
| Measure |
Carcinoembryonic Antigen (CEA)-Tricom Vaccines
n=37 participants at risk
(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10\^8 plaque-forming unit (pfu) x 1 dose subcutaneously
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
13.5%
5/37 • Number of events 7 • 91 months
|
|
Blood and lymphatic system disorders
Platelets
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Cardiac disorders
Hypotension
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Cardiac disorders
Thrombosis/embolism
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Prothrombin time (PT)
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0x10e9/L)
|
13.5%
5/37 • Number of events 7 • 91 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Hepatobiliary disorders
Bilirubin
|
5.4%
2/37 • Number of events 4 • 91 months
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Hepatobiliary disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Hepatobiliary disorders
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Infections and infestations
Catheter-related infection
|
13.5%
5/37 • Number of events 7 • 91 months
|
|
Infections and infestations
Febrile neutropenia
|
21.6%
8/37 • Number of events 13 • 91 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e
|
5.4%
2/37 • Number of events 3 • 91 months
|
|
Infections and infestations
Infection without neutropenia
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other (Specify, infection:catheter-related infection)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Nervous system disorders
Confusion
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Nervous system disorders
Dizziness/lightheadedness
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Renal and urinary disorders
Creatinine
|
2.7%
1/37 • Number of events 1 • 91 months
|
Other adverse events
| Measure |
Carcinoembryonic Antigen (CEA)-Tricom Vaccines
n=37 participants at risk
(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10\^8 plaque-forming unit (pfu) x 1 dose subcutaneously
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.8%
4/37 • Number of events 4 • 91 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
10.8%
4/37 • Number of events 4 • 91 months
|
|
Immune system disorders
Allergy-Other (Specify, itching & red splotches due to shellfish)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Immune system disorders
Autoimmune reaction
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
27.0%
10/37 • Number of events 172 • 91 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
27.0%
10/37 • Number of events 169 • 91 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
27.0%
10/37 • Number of events 70 • 91 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
27.0%
10/37 • Number of events 118 • 91 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Platelets
|
27.0%
10/37 • Number of events 11 • 91 months
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
13.5%
5/37 • Number of events 11 • 91 months
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
18.9%
7/37 • Number of events 23 • 91 months
|
|
General disorders
Edema
|
8.1%
3/37 • Number of events 3 • 91 months
|
|
General disorders
Hypotension
|
8.1%
3/37 • Number of events 3 • 91 months
|
|
General disorders
Phlebitis (superficial)
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Investigations
Fibrinogen
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Investigations
Partial thromboplastin time (PTT)
|
16.2%
6/37 • Number of events 11 • 91 months
|
|
Investigations
Prothrombin time (PT)
|
5.4%
2/37 • Number of events 3 • 91 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
21.6%
8/37 • Number of events 31 • 91 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0x10e9/L)
|
18.9%
7/37 • Number of events 12 • 91 months
|
|
General disorders
Rigors, chills
|
16.2%
6/37 • Number of events 11 • 91 months
|
|
General disorders
Sweating (diaphoresis)
|
8.1%
3/37 • Number of events 3 • 91 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.2%
6/37 • Number of events 6 • 91 months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
27.0%
10/37 • Number of events 35 • 91 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
5.4%
2/37 • Number of events 4 • 91 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Skin and subcutaneous tissue disorders
Wound-infectious
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Endocrine disorders
Endocrine-Other (Specify,endocrine-other: hyperthyroid)
|
5.4%
2/37 • Number of events 3 • 91 months
|
|
Endocrine disorders
Hot flashes/flushes
|
8.1%
3/37 • Number of events 3 • 91 months
|
|
Endocrine disorders
Hypothyroidism
|
2.7%
1/37 • Number of events 2 • 91 months
|
|
Gastrointestinal disorders
Anorexia
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Gastrointestinal disorders
Constipation
|
5.4%
2/37 • Number of events 3 • 91 months
|
|
Gastrointestinal disorders
Dehydration
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
18.9%
7/37 • Number of events 15 • 91 months
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
8.1%
3/37 • Number of events 6 • 91 months
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
10.8%
4/37 • Number of events 7 • 91 months
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify,gastrointestinal:hemorrhoid; indigestion)
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Gastrointestinal disorders
Nausea
|
21.6%
8/37 • Number of events 19 • 91 months
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
21.6%
8/37 • Number of events 12 • 91 months
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
5/37 • Number of events 12 • 91 months
|
|
Blood and lymphatic system disorders
Epistaxis
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Hematuria (in the absence of vaginal bleeding)
|
13.5%
5/37 • Number of events 13 • 91 months
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
13.5%
5/37 • Number of events 11 • 91 months
|
|
Hepatobiliary disorders
Bilirubin
|
13.5%
5/37 • Number of events 11 • 91 months
|
|
Hepatobiliary disorders
Hepatic-Other (Specify, albumin_serum low)
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
24.3%
9/37 • Number of events 56 • 91 months
|
|
Blood and lymphatic system disorders
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
27.0%
10/37 • Number of events 36 • 91 months
|
|
Hepatobiliary disorders
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
24.3%
9/37 • Number of events 36 • 91 months
|
|
Infections and infestations
Catheter-related infection
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Infections and infestations
Febrile neutropenia
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC<1.0x10e9/L
|
8.1%
3/37 • Number of events 8 • 91 months
|
|
Infections and infestations
Infection without neutropenia
|
16.2%
6/37 • Number of events 18 • 91 months
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other (Specify, infection: other:viral; infection: sinusitis)
|
5.4%
2/37 • Number of events 3 • 91 months
|
|
Blood and lymphatic system disorders
Lymphatics
|
5.4%
2/37 • Number of events 2 • 91 months
|
|
Blood and lymphatic system disorders
Lymphatics-Other (Specify, lymphedema)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Metabolism and nutrition disorders
Bicarbonate
|
10.8%
4/37 • Number of events 7 • 91 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.7%
1/37 • Number of events 4 • 91 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.0%
10/37 • Number of events 49 • 91 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.1%
3/37 • Number of events 3 • 91 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.8%
4/37 • Number of events 5 • 91 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.7%
1/37 • Number of events 2 • 91 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.1%
3/37 • Number of events 6 • 91 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
27.0%
10/37 • Number of events 45 • 91 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.0%
10/37 • Number of events 19 • 91 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.2%
6/37 • Number of events 20 • 91 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.0%
10/37 • Number of events 32 • 91 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.9%
7/37 • Number of events 17 • 91 months
|
|
Metabolism and nutrition disorders
Musculoskeletal-Other (Specify, pain other: tenderness at catheter site; pain: cathether placement)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Nervous system disorders
Dizziness/lightheadedness
|
8.1%
3/37 • Number of events 3 • 91 months
|
|
Nervous system disorders
Insomnia
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Nervous system disorders
Mood alteration-anxiety, agitation
|
2.7%
1/37 • Number of events 2 • 91 months
|
|
Nervous system disorders
Mood alteration-depression
|
8.1%
3/37 • Number of events 3 • 91 months
|
|
Nervous system disorders
Neuropathy-sensory
|
10.8%
4/37 • Number of events 4 • 91 months
|
|
Nervous system disorders
Syncope (fainting)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Nervous system disorders
Tremor
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Eye disorders
Keratitis (corneal inflammation/corneal ulceration)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Eye disorders
Vision-blurred vision
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
5.4%
2/37 • Number of events 3 • 91 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
10.8%
4/37 • Number of events 4 • 91 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.8%
4/37 • Number of events 5 • 91 months
|
|
General disorders
Chest pain (non-cardiac and non-pleuritic)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Number of events 9 • 91 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
10.8%
4/37 • Number of events 6 • 91 months
|
|
General disorders
Pain-Other (Specify, Pain Other: tenderness at catheter site)
|
10.8%
4/37 • Number of events 5 • 91 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
6/37 • Number of events 8 • 91 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.8%
4/37 • Number of events 5 • 91 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.7%
1/37 • Number of events 3 • 91 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other (Specify, Pulmonary Other: bronchospasm/wheezing)
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Renal and urinary disorders
Creatinine
|
2.7%
1/37 • Number of events 2 • 91 months
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
10.8%
4/37 • Number of events 4 • 91 months
|
|
Renal and urinary disorders
Incontinence
|
2.7%
1/37 • Number of events 1 • 91 months
|
|
Renal and urinary disorders
Proteinuria
|
16.2%
6/37 • Number of events 17 • 91 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.4%
2/37 • Number of events 3 • 91 months
|
|
Renal and urinary disorders
Urine color change (not related to other dietary or physiologic cause e.g., bilirubin, concentrated
|
2.7%
1/37 • Number of events 1 • 91 months
|
Additional Information
Claude Sportes, M.D.
National Cancer Institute (NCI), National Institutes of Health (NIH)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place