Trial Outcomes & Findings for Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer (NCT NCT00322881)
NCT ID: NCT00322881
Last Updated: 2018-09-10
Results Overview
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Results posted on
2018-09-10
Participant Flow
12 patients were enrolled between March 26, 2006 and January 2, 2008.
Participant milestones
| Measure |
Carboplatin/Paclitaxel
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
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|---|---|
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Overall Study
STARTED
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12
|
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Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Carboplatin/Paclitaxel
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
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|---|---|
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Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease Progression
|
2
|
Baseline Characteristics
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel
n=12 Participants
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
78.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.Population: The analysis dataset is comprised of all treated patients.
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
Outcome measures
| Measure |
Carboplatin/Paclitaxel
n=12 Participants
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
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|---|---|
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Therapy Completion Rate
|
.50 proportion of participants
Interval 0.245 to 0.755
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Adverse Events
Carboplatin/Paclitaxel
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel
n=12 participants at risk
Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Gastrointestinal disorders
GI-other
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
General disorders
Fatigue
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Infections and infestations
Infection w/ gr3-4 neut, anal/perianal
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Infections and infestations
Infection-other
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
Neutrophils
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Renal and urinary disorders
Incontinence urinary
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel
n=12 participants at risk
Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
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|---|---|
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Blood and lymphatic system disorders
Hemoglobin
|
25.0%
3/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
6/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
General disorders
Fatigue
|
50.0%
6/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
General disorders
Injection site reaction
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
General disorders
Pain NOS
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
General disorders
Pain-other
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Infections and infestations
Infection-other
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
Leukocytes
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
Neutrophils
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
Platelets
|
25.0%
3/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
Alkaline phosphatase
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
ALT, SGPT
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
AST, SGOT
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
Creatinine
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Investigations
Metabolic/Laboratory-other
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
4/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
16.7%
2/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Nervous system disorders
Neuropathy-sensory
|
50.0%
6/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Nervous system disorders
Neurologic-other
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.3%
7/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.3%
1/12 • The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place