Trial Outcomes & Findings for Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma (NCT NCT02788201)
NCT ID: NCT02788201
Last Updated: 2020-11-06
Results Overview
Participants were assigned a treatment combination by the co-expression extrapolation (COXEN) algorithm. The COXEN algorithm used a multi-step process that involved pathology, tissue processing, messenger ribonucleic acid (mRNA) profiling and bioinformatics, etc. to select a treatment regimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
time to treatment assignment, approximately 3 weeks
Results posted on
2020-11-06
Participant Flow
Participant milestones
| Measure |
Doxorubicin 75mg/m^2
All participants that received Doxorubicin 75mg/m\^2.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
3
|
|
Overall Study
Did Not Start Treatment
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Doxorubicin 75mg/m^2
All participants that received Doxorubicin 75mg/m\^2.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Ineligible
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Doxorubicin 75mg/m^2
n=1 Participants
All participants that received Doxorubicin 75mg/m\^2.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
n=1 Participants
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
n=1 Participants
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
n=1 Participants
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
n=1 Participants
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
n=3 Participants
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Age, Continuous
|
72.1 years
STANDARD_DEVIATION 0 • n=5 Participants
|
60 years
STANDARD_DEVIATION 0 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 0 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 0 • n=4 Participants
|
62 years
STANDARD_DEVIATION 0 • n=21 Participants
|
58.43 years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
61.86 years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=8 Participants
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: time to treatment assignment, approximately 3 weeksPopulation: This primary measure was to determine the feasibility of the COXEN algorithm. Data collected from participants receiving different treatments were combined and analyzed as a single group as pre-specified in the study protocol.
Participants were assigned a treatment combination by the co-expression extrapolation (COXEN) algorithm. The COXEN algorithm used a multi-step process that involved pathology, tissue processing, messenger ribonucleic acid (mRNA) profiling and bioinformatics, etc. to select a treatment regimen.
Outcome measures
| Measure |
All COXEN Participants Enrolled
n=8 Participants
All participants who were enrolled that signed consent and received Doxorubicin 75mg/m\^2, Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg, Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
Three participants were enrolled to this study but never started treatment. Treatment was assigned on course initiation.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Enrolled and Underwent a Biopsy Who Went on to Receive Treatment Within 21 Days
|
63 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 2 cycles until progression, approximately 4 months.Population: Not all patients enrolled received a treatment from the treatment algorithm. Those that went on for treatment were evaluated for progression free survival within the 4-month times frame. Data collected from participants receiving different treatments were combined and analyzed as a single group as pre-specified in the study protocol.
Progression Free Survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Radiological assessment per the Response Evaluation Criteria in Solid Tumors (RECIST) was done every 2 cycles to measure change in tumor size until tumors increased. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study; this includes the baseline sum if that is the smallest on study. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
All COXEN Participants Enrolled
n=5 Participants
All participants who were enrolled that signed consent and received Doxorubicin 75mg/m\^2, Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg, Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
Three participants were enrolled to this study but never started treatment. Treatment was assigned on course initiation.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival
|
2.2 Months
Interval 1.4 to 3.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End of treatment, approximately 4 months.Population: Not all patients enrolled received a treatment from the treatment algorithm. We included all patient who received treatment in this group. Data collected from participants receiving different treatments were combined and analyzed as a single group as pre-specified in the study protocol.
Objective Response is defined as a Complete Response and Partial Response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
All COXEN Participants Enrolled
n=5 Participants
All participants who were enrolled that signed consent and received Doxorubicin 75mg/m\^2, Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg, Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
Three participants were enrolled to this study but never started treatment. Treatment was assigned on course initiation.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With an Objective Response
Complete Response
|
0 proportion of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Patients With an Objective Response
Partial Response
|
0 proportion of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of treatment content until the date of death from any cause or date off study, whichever came first, assessed up to 10 months and 16 days.Population: Data collected from participants receiving different treatments were combined and analyzed as a single group as pre-specified in the study protocol.
Amount of time subject survives without disease progression after treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
All COXEN Participants Enrolled
n=5 Participants
All participants who were enrolled that signed consent and received Doxorubicin 75mg/m\^2, Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg, Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
Three participants were enrolled to this study but never started treatment. Treatment was assigned on course initiation.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
8.4 Months
Interval 5.2 to
There is insufficient data to calculate the upper limit confidence interval.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approx. 5 mos/ 6 dys for the 1st Grp; 10 mos/16 dys for the 2nd Grp; 8 mos/13 dys for the 3rd Grp; 5 mos/16 dys for the 4th Grp; and 27 dys for the 5th Grp.Population: Adverse Events were not monitored for those participants who were enrolled but not treated.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is death.
Outcome measures
| Measure |
All COXEN Participants Enrolled
n=1 Participants
All participants who were enrolled that signed consent and received Doxorubicin 75mg/m\^2, Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg, Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
Three participants were enrolled to this study but never started treatment. Treatment was assigned on course initiation.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
n=1 Participants
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
n=1 Participants
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
n=1 Participants
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
n=1 Participants
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Infections & Infestations-Other, Bactremia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 5 - Death NOS
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 2 Dysgeusia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Anemia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Fatigue
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Febrile neutropenia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Gastrointestinal disorders - Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Generalized muscle weakness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 GI disorder-Other, hernia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Thromboembolic event
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Hyponatremia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Hypophosphatemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Platelet count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 Small intestinal obstruction
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 3 White blood cell count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 4 Neutrophil count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 4 Platelet count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Adverse Events ≥ Grade 1
Grade 4 White blood cell count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approx. 5 mos/ 6 dys for the 1st Grp; 10 mos/16 dys for the 2nd Grp; 8 mos/13 dys for the 3rd Grp; 5 mos/16 dys for the 4th Grp; and 27 dys for the 5th Grp.Population: Adverse Events were not monitored for those participants who were enrolled but not treated.
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All COXEN Participants Enrolled
n=1 Participants
All participants who were enrolled that signed consent and received Doxorubicin 75mg/m\^2, Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg, Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2, Sunitinib 50mg, Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
Three participants were enrolled to this study but never started treatment. Treatment was assigned on course initiation.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
n=1 Participants
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
n=1 Participants
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
n=1 Participants
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
n=1 Participants
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
n=1 Participants
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Doxorubicin 75mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Sunitinib 50mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants Who Were Enrolled But Not Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Doxorubicin 75mg/m^2
n=1 participants at risk
All participants that received Doxorubicin 75mg/m\^2.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
n=1 participants at risk
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
n=1 participants at risk
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
n=1 participants at risk
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
n=1 participants at risk
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
General disorders
Death NOS
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
Other adverse events
| Measure |
Doxorubicin 75mg/m^2
n=1 participants at risk
All participants that received Doxorubicin 75mg/m\^2.
|
Paclitaxel 100 mg/m^2 and Erlotinib 150 mg
n=1 participants at risk
All participants that received Paclitaxel 100 mg/m\^2 and Erlotinib 150 mg.
|
Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2
n=1 participants at risk
All participants that received Paclitaxel 135mg/m\^2 and Doxorubicin 40mg/m\^2.
|
Sunitinib 50mg
n=1 participants at risk
All participants that received Sunitinib 50mg.
|
Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2
n=1 participants at risk
All participants that received Vorinostat 500mg and Etoposide 100mg/m\^2 and 60mg/m\^2.
|
Participants Who Were Enrolled But Not Treated
3 participants were enrolled and signed consent to this study but never started treatment. Treatment was assigned on course initiation.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Hernia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Infections and infestations
Infections and infestations - Other, Bacteremia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
|
Investigations
Febrile Neutropenia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 6 days for the Doxorubicin 75mg/m^2 Arm/Group, 10 months and 16 days for the Paclitaxel 100 mg/m^2 and Erlotinib 150 mg Arm/Group, 8 months and 13 days for the Paclitaxel 135mg/m^2 and Doxorubicin 40mg/m^2 Arm/Group, 5 months and 16 days for the Sunitinib 50mg Arm/Group, 27 days for the Vorinostat 500mg and Etoposide 100mg/m^2 and 60mg/m^2 Arm/Group.
Serious and Other (Not Including Serious) Adverse Events were not monitored for those participants who were enrolled but not treated. However, All-Cause Mortality was monitored for one participant in the Participants Who Were Enrolled But Not Treated Arm/Group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place