Trial Outcomes & Findings for Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer (NCT NCT00534417)
NCT ID: NCT00534417
Last Updated: 2013-02-01
Results Overview
Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.
Results posted on
2013-02-01
Participant Flow
5 community oncology research sites across the US associated with ACORN participated in this study. Enrollment started in February 2008 and was completed in May 2010.
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
Participant milestones
| Measure |
Capecitabine and Fulvestrant
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg orally (po) in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment Group: Capecitabine/Fulvestrant
n=41 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age Continuous
|
64.5 years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.Population: 21 patients had experienced disease progression. 20 patients were censored in TTP analysis. The 3 deaths in the PFS analysis were censored for the TTP analysis.
Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=41 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Time to Progression (TTP)
|
26.94 Months
95% Confidence Interval 1.84 • Interval 7.26 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
PRIMARY outcome
Timeframe: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months.Population: 21 patients had experienced disease progression, and three had died. 17 patients were censored in PFS analysis.
Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=41 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Progression-free Survival (PFS)
|
14.98 Months
Interval 7.26 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Response to treatment was assessed after every 8 weeks of treatmentBest overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=41 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
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|---|---|
|
Best Overall Response
Progressive disease (PD)
|
3 participants
|
|
Best Overall Response
Complete response (CR)
|
2 participants
|
|
Best Overall Response
Partial response (PR)
|
8 participants
|
|
Best Overall Response
Stable disease (SD)
|
28 participants
|
SECONDARY outcome
Timeframe: Response to treatment was assessed after every 8 weeks of treatmentOverall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=41 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
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|---|---|
|
Overall Response Rate
|
24.4 percentage of participants
Interval 10.0 to 38.8
|
SECONDARY outcome
Timeframe: Response to treatment was assessed after every 8 weeks of treatmentClinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of \>=20%.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=41 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
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|---|---|
|
Clinical Benefit Rate
|
58.5 percentage of participants
Interval 42.2 to 73.3
|
SECONDARY outcome
Timeframe: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.Population: Participants who had questionnaire data available.
The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=30 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
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Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Vaginal dryness
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Bruising
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Dry skin
|
13.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Hair loss
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Burning sensation in hands or feet
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Daytime sleepiness
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Hives/Welts
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Sinus problems
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Swelling
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Fatigue
|
26.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Weight loss
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Change in taste
|
6.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Difficulty hearing
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Reduced sexual enjoyment, interest, or performance
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Dry eyes
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Tearing
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Trouble seeing
|
16.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Constipation
|
20.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Decrease in appetite
|
6.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Diarrhea
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Heartburn
|
6.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Increase in appetite
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Problem with urination
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
New lump/mass
|
6.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Breast tenderness
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Itching
|
13.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Nails change
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Joint pain
|
26.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Muscle aches
|
26.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Weakness of body parts
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Dizziness/lightheadedness
|
3.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Memory loss
|
6.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Numbness/tingling
|
13.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Trouble thinking
|
10.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Headache
|
6.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Pain
|
26.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Coughing
|
13.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Shortness of breath
|
6.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Symptoms)
Wheezing
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.Population: Participants who had questionnaire data available.
The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=29 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Crying/feeling like crying
|
10.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Feeling helpless
|
6.9 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Feeling hopeless
|
10.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Feeling I would be better off dead
|
3.4 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Lost interest in people
|
3.4 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Lost interest in pleasurable activities
|
10.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Nervous, tense, anxious
|
13.8 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Sad/depressed
|
10.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)
Worry
|
10.3 percentage of participants
|
SECONDARY outcome
Timeframe: The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.Population: Participants who had questionnaire data available. Note that 4 items only had data available from 27 participants rather than 28.
The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response \> or = to 7 on an item.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=28 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
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Patients Experiencing Severe Symptom Burden (Physical Functioning)
Attend social activity
|
7.1 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Bathe or dress self
|
10.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Attend paid job (N=27)
|
37.0 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Cook for self
|
10.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Driving (N=27)
|
25.9 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Function normally
|
14.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Hard work or activity (N=27)
|
33.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Household work
|
21.4 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Light work or activity
|
10.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Run (N=27)
|
33.3 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Run errands
|
17.9 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Sit up
|
10.7 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Stay out of bed
|
7.1 percentage of participants
|
|
Patients Experiencing Severe Symptom Burden (Physical Functioning)
Walk
|
17.9 percentage of participants
|
POST_HOC outcome
Timeframe: OS was measured from day 1 of treatment until time of death from any cause, up to 32.5 months.Population: 14 patients had died, and 27 patients were censored in the OS analysis.
Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.
Outcome measures
| Measure |
Capecitabine and Fulvestrant
n=41 Participants
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Overall Survival (OS)
|
28.65 Months
Interval 23.95 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
Adverse Events
Treatment Group: Capecitabine/Fulvestrant
Serious events: 9 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group: Capecitabine/Fulvestrant
n=41 participants at risk
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Cardiac disorders
Cardiac Tamponade
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Cardiac disorders
Pericardial Effusion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Adverse Drug Reaction
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Pneumonia
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
Other adverse events
| Measure |
Treatment Group: Capecitabine/Fulvestrant
n=41 participants at risk
Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.
Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Discomfort
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Pain
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Pyrexia
|
12.2%
5/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic Diathesis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Ear and labyrinth disorders
Ear Pain
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Endocrine disorders
Hyperparathyroidism
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Diplopia
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Dry Eye
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Glaucoma
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Lacrimation Increased
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Vision Blurred
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Visual Impairment
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
17.1%
7/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.4%
10/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
31.7%
13/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
19.5%
8/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Asthenia
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Axillary Pain
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Chest Discomfort
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Chest Pain
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Chills
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Device Occlusion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Face Oedema
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Fatigue
|
39.0%
16/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Gait Disturbance
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Immediate Post-Injection Reaction
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Influenza Like Illness
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Injection Site Pain
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Injection Site Pruritus
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Mucosal Inflammation
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Oedema
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Oedema Peripheral
|
24.4%
10/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Bronchitis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Candidiasis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Cellulitis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Cystitis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Fungal Skin Infection
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Herpes Zoster
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Nail Infection
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Pharyngitis
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Skin Infection
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Tooth Infection
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
12.2%
5/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Vaginal Infection
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Wound Infection
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Seroma
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Alanine Aminotransferase Decreased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Blood Creatinine Increased
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Blood Pressure Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Breath Sounds Abnormal
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Creatinine Renal Clearance Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Heart Rate Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Protein Total Decreased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Prothrombin Level Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Prothrombin Time Prolonged
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Thyroid Function Test Abnormal
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Vitamin D Decreased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Weight Decreased
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Weight Increased
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.1%
7/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.5%
8/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
19.5%
8/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Mass
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
22.0%
9/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma Stage 0
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Haemangioma
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Amnesia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Burning Feet Syndrome
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Burning Sensation
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Cerebral Ischaemia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Dizziness
|
17.1%
7/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
14.6%
6/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Headache
|
24.4%
10/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Memory Impairment
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Mental Impairment
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Migraine
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Neuropathy Peripheral
|
17.1%
7/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Parosmia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Restless Legs Syndrome
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Sciatica
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Sinus Headache
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Anxiety
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Depression
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Urinary Retention
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Breast Pain
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
10/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
5/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discharge Discolouration
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
12.2%
5/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Increased Tendency To Bruise
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
41.5%
17/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.2%
5/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
19.5%
8/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Sensitisation
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Hot Flush
|
9.8%
4/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Hypertension
|
7.3%
3/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Lymphoedema
|
4.9%
2/41 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
Additional Information
Vice President of Scientific Affairs
Accelerated Community Oncology Research Network, Inc.
Phone: 901-435-5570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall submit a copy of any manuscript or material proposed for publication or the text of any presentation relating to the results of the Study to AstraZeneca and Roche for review and comment at least 30 days prior to its submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER