Trial Outcomes & Findings for An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer (NCT NCT01725386)
NCT ID: NCT01725386
Last Updated: 2016-09-28
Results Overview
To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.
Recruitment status
COMPLETED
Target enrollment
274 participants
Primary outcome timeframe
Up to approximately 4 years
Results posted on
2016-09-28
Participant Flow
274 participants were enrolled in the study; of these, 23 participants from 3 centers were excluded from the analysis due to study termination at those 3 centers. The remaining 251 participants were eligible for analysis.
Participant milestones
| Measure |
Monotherapy
Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
63
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
175
|
46
|
Reasons for withdrawal
| Measure |
Monotherapy
Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Overall Study
Death
|
84
|
40
|
|
Overall Study
Lost to Follow-up
|
81
|
6
|
|
Overall Study
Withdrawal by Subject
|
10
|
0
|
Baseline Characteristics
An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Monotherapy
n=188 Participants
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 Participants
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.00 years
STANDARD_DEVIATION 12.35 • n=99 Participants
|
45.00 years
STANDARD_DEVIATION 15.19 • n=107 Participants
|
47.00 years
STANDARD_DEVIATION 12.11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
251 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 4 yearsPopulation: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.
Outcome measures
| Measure |
Monotherapy
n=188 Participants
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 Participants
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
Second Line
|
71.8 percentage of participants
|
41.3 percentage of participants
|
|
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
First Line
|
10.6 percentage of participants
|
55.6 percentage of participants
|
|
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
Third Line
|
17.6 percentage of participants
|
3.1 percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately 4 yearsPopulation: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.
Outcome measures
| Measure |
Monotherapy
n=188 Participants
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 Participants
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Percentage of Participants Receiving Concomitant Medications During the Study
|
17.5 percentage of participants
|
23.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.
Outcome measures
| Measure |
Monotherapy
n=188 Participants
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 Participants
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Percentage of Participants With Relevant Medical History Assessed at Baseline
History of Other Types of Cancer
|
0.5 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Relevant Medical History Assessed at Baseline
Family History of Breast Cancer
|
9.6 percentage of participants
|
12.7 percentage of participants
|
|
Percentage of Participants With Relevant Medical History Assessed at Baseline
History of Co-morbidities
|
18.1 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With Relevant Medical History Assessed at Baseline
Premenopausal Status
|
54.8 percentage of participants
|
41.3 percentage of participants
|
|
Percentage of Participants With Relevant Medical History Assessed at Baseline
Postmenopausal Status
|
45.2 percentage of participants
|
58.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.
Outcome measures
| Measure |
Monotherapy
n=188 Participants
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 Participants
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
Moderately Differentiated
|
42.6 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
Well Differentiated
|
9.0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
Poorly Differentiated/Undifferentiated
|
48.4 percentage of participants
|
46.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
Outcome measures
| Measure |
Monotherapy
n=188 Participants
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 Participants
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Mean Survival Time
|
15.493 Months
Interval 14.169 to 16.817
|
15.417 Months
Interval 13.512 to 17.322
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
Outcome measures
| Measure |
Monotherapy
n=188 Participants
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 Participants
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
45.2 percentage of participants
|
66.7 percentage of participants
|
Adverse Events
Monotherapy
Serious events: 85 serious events
Other events: 73 other events
Deaths: 0 deaths
Combination Therapy
Serious events: 42 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monotherapy
n=188 participants at risk
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 participants at risk
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
35.1%
66/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
42.9%
27/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
4.8%
3/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
3.2%
2/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Melena
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
4.8%
3/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Ascites
|
1.6%
3/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
6.3%
4/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
4.8%
3/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Head Ache
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Body Ache
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Drowsiness
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
High grade fever
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Fever
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Diabetic Coma
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Semi conscous/Unconsciousness
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
4.8%
3/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Multiple Organ Failure
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Hepatobiliary disorders
Hepatic failure with Ascites
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Infections and infestations
Cerebral Inflammation
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Infections and infestations
Pyogenic Meningitis
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Infections and infestations
Septicemia & Anaemia
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Infections and infestations
Infected chest wound
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Investigations
Jaundice
|
2.1%
4/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
3.2%
2/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in sternum
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Nervous system disorders
Generalized Fits
|
1.1%
2/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
3.2%
2/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Reproductive system and breast disorders
Excessive bleeding from Right breast mass
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Reproductive system and breast disorders
Nodules on Right chest & Axilla
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
3/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
6.3%
4/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.7%
5/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
4.8%
3/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress/Failure
|
5.3%
10/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
11.1%
7/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
1.6%
1/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Chest Infection
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
3.2%
2/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
2/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
4.8%
3/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Skin and subcutaneous tissue disorders
Skin cutaneous Infiltration
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Vascular disorders
Hypotension
|
0.53%
1/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
Other adverse events
| Measure |
Monotherapy
n=188 participants at risk
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
|
Combination Therapy
n=63 participants at risk
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
9.5%
6/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
13/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
19.0%
12/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Nausea
|
4.3%
8/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
20.6%
13/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Stomatitis
|
2.1%
4/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
20.6%
13/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
16/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
25.4%
16/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Fatigue
|
6.9%
13/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
9.5%
6/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Peripheral edema
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
9.5%
6/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
General disorders
Pyrexia
|
2.7%
5/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
9.5%
6/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
2/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
9.5%
6/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.9%
11/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
0.00%
0/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
12.7%
8/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
|
Skin and subcutaneous tissue disorders
Hand-and-Foot Syndrome
|
10.6%
20/188 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
27.0%
17/63 • Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER