Trial Outcomes & Findings for Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer (NCT NCT00080301)
NCT ID: NCT00080301
Last Updated: 2020-11-02
Results Overview
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
752 participants
Primary outcome timeframe
based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Results posted on
2020-11-02
Participant Flow
Participant milestones
| Measure |
Ixabepilone + Capecitabine
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
375
|
377
|
|
Overall Study
Never Treated
|
5
|
10
|
|
Overall Study
Still on Treatment
|
0
|
1
|
|
Overall Study
COMPLETED
|
370
|
366
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
Ixabepilone + Capecitabine
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Overall Study
Randomized but Never Treated
|
5
|
10
|
|
Overall Study
Still on Treatment as of CSR date
|
0
|
1
|
Baseline Characteristics
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone + Capecitabine
n=375 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=377 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
Total
n=752 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
336 participants
n=5 Participants
|
322 participants
n=7 Participants
|
658 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
39 participants
n=5 Participants
|
54 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Age, Customized
<50 years
|
135 participants
n=5 Participants
|
145 participants
n=7 Participants
|
280 participants
n=5 Participants
|
|
Age, Customized
>= 50 years
|
240 participants
n=5 Participants
|
231 participants
n=7 Participants
|
471 participants
n=5 Participants
|
|
Age, Customized
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Continuous
|
53.0 years
n=5 Participants
|
52.0 years
n=7 Participants
|
53.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
375 Participants
n=5 Participants
|
376 Participants
n=7 Participants
|
751 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
83 participants
n=5 Participants
|
87 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
257 participants
n=5 Participants
|
247 participants
n=7 Participants
|
504 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
23 participants
n=5 Participants
|
32 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Disease Sites
Ascites
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Disease Sites
Bone
|
168 participants
n=5 Participants
|
162 participants
n=7 Participants
|
330 participants
n=5 Participants
|
|
Disease Sites
Breast
|
61 participants
n=5 Participants
|
63 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Disease Sites
Chest Wall
|
53 participants
n=5 Participants
|
53 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Disease Sites
Effusion
|
57 participants
n=5 Participants
|
55 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Disease Sites
Lymph Node
|
250 participants
n=5 Participants
|
249 participants
n=7 Participants
|
499 participants
n=5 Participants
|
|
Disease Sites
Other
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Disease Sites
Peritoneum
|
7 participants
n=5 Participants
|
14 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Disease Sites
Pleura
|
29 participants
n=5 Participants
|
35 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Disease Sites
Skin/Soft Tissue
|
60 participants
n=5 Participants
|
62 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Disease Sites
Visceral, Liver
|
245 participants
n=5 Participants
|
228 participants
n=7 Participants
|
473 participants
n=5 Participants
|
|
Disease Sites
Visceral, Lung
|
180 participants
n=5 Participants
|
174 participants
n=7 Participants
|
354 participants
n=5 Participants
|
|
Disease Sites
Visceral, Other
|
34 participants
n=5 Participants
|
28 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Disease Sites at Baseline
Liver ± Lung ± Skin/Soft Tissue ± Bone
|
245 participants
n=5 Participants
|
228 participants
n=7 Participants
|
473 participants
n=5 Participants
|
|
Disease Sites at Baseline
Lung ± Skin/Soft Tissue ± Bone
|
71 participants
n=5 Participants
|
87 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Disease Sites at Baseline
Skin/Soft Tissue ± Bone
|
49 participants
n=5 Participants
|
52 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Disease Sites at Baseline
Bone
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Disease Sites at Baseline
Other
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Karnofsky Performance Status
100
|
108 Units on a scale
n=5 Participants
|
105 Units on a scale
n=7 Participants
|
213 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
90
|
145 Units on a scale
n=5 Participants
|
132 Units on a scale
n=7 Participants
|
277 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
80
|
86 Units on a scale
n=5 Participants
|
102 Units on a scale
n=7 Participants
|
188 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
70
|
33 Units on a scale
n=5 Participants
|
34 Units on a scale
n=7 Participants
|
67 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
<70
|
0 Units on a scale
n=5 Participants
|
1 Units on a scale
n=7 Participants
|
1 Units on a scale
n=5 Participants
|
|
Karnofsky Performance Status
Not reported
|
3 Units on a scale
n=5 Participants
|
3 Units on a scale
n=7 Participants
|
6 Units on a scale
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
54 participants
n=5 Participants
|
51 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Menopausal Status
Perimenopausal
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
288 participants
n=5 Participants
|
289 participants
n=7 Participants
|
577 participants
n=5 Participants
|
|
Menopausal Status
Not reported
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Number of Disease Sites
1 disease site
|
39 participants
n=5 Participants
|
34 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Number of Disease Sites
2 disease sites
|
85 participants
n=5 Participants
|
98 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Number of Disease Sites
3 disease sites
|
110 participants
n=5 Participants
|
121 participants
n=7 Participants
|
231 participants
n=5 Participants
|
|
Number of Disease Sites
4 disease sites
|
79 participants
n=5 Participants
|
69 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Number of Disease Sites
≥5 disease sites
|
58 participants
n=5 Participants
|
53 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Presence of All Lesions
Subjects with at least 1 lesion
|
371 participants
n=5 Participants
|
375 participants
n=7 Participants
|
746 participants
n=5 Participants
|
|
Presence of All Lesions
Subjects with no lesions
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Visceral Disease in Liver and/or Lung
Yes
|
316 participants
n=5 Participants
|
315 participants
n=7 Participants
|
631 participants
n=5 Participants
|
|
Visceral Disease in Liver and/or Lung
No
|
55 participants
n=5 Participants
|
60 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Visceral Disease in Liver and/or Lung
Missing
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicityPopulation: PFS was analyzed on all randomized patients on an intention to treat basis.
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=375 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=377 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
|
5.85 Months
Interval 5.45 to 6.97
|
4.17 Months
Interval 3.81 to 4.5
|
SECONDARY outcome
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicityPopulation: The analysis of ORR was conducted on all randomized patients on an intent to treat basis.
Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=375 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=377 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Overall Response Rate (ORR) Per IRRC
|
34.7 percent
Interval 29.9 to 39.7
|
14.3 percent
Interval 10.9 to 18.3
|
SECONDARY outcome
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicityPopulation: Results for duration of response apply to only those subjects with a response (defined as complete or partial response).
Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=130 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=54 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Duration of Response Per IRRC
|
6.4 months
Interval 5.6 to 7.1
|
5.6 months
Interval 4.2 to 7.5
|
SECONDARY outcome
Timeframe: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicityPopulation: Results for time to response apply to only those subjects with a response (defined as complete or partial response)
Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=130 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=54 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Time to Response Per IRRC
|
11.7 weeks
Interval 4.4 to 61.4
|
12.0 weeks
Interval 4.3 to 41.9
|
SECONDARY outcome
Timeframe: from date of randomization until deathPopulation: Overall survival was analyzed on all randomized patients on an intent to treat basis.
OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=375 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=377 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Overall Survival (OS)
|
12.9 Months
Interval 11.5 to 14.2
|
11.1 Months
Interval 10.0 to 12.5
|
SECONDARY outcome
Timeframe: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.Population: All treated participants; all participants who received at least 1 dose of study therapy.Participants with baseline hepatic impairment (combination arm, n = 29; capecitabine arm, n = 35), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths.
Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=369 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=368 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Treatment-related Safety Summary
Deaths on-study or within 30 days of last dose
|
33 Participants
|
40 Participants
|
|
Treatment-related Safety Summary
Treatment-related Serious Adverse Events (SAEs)
|
91 Participants
|
31 Participants
|
|
Treatment-related Safety Summary
Treatment-related Adverse Events (AEs)
|
357 Participants
|
330 Participants
|
|
Treatment-related Safety Summary
Treatment-related AEs leading to Discontinuation
|
137 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.Population: Analysis was conducted on all randomized participants on an intent to treat basis.(Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)
Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=375 Participants
Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
|
Capecitabine
n=377 Participants
Capecitabine 1250 mg/m2 BID x 14 days
|
|---|---|---|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 3 (n=282; n=273)
|
-0.4 units on a scale
Interval -0.97 to 0.2
|
0.3 units on a scale
Interval -0.28 to 0.84
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 6 (n=227; n=214)
|
-0.2 units on a scale
Interval -0.9 to 0.48
|
1.1 units on a scale
Interval 0.3 to 1.83
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 9 (n=194; n=184)
|
-0.6 units on a scale
Interval -1.31 to 0.19
|
1.8 units on a scale
Interval 0.97 to 2.58
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 12 (n=173; n=158)
|
-1.3 units on a scale
Interval -2.19 to -0.42
|
1.4 units on a scale
Interval 0.55 to 2.18
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 15 (n=148; n=145)
|
-0.7 units on a scale
Interval -1.65 to 0.27
|
1.7 units on a scale
Interval 0.73 to 2.72
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 18 (n=122; n=121)
|
-1.0 units on a scale
Interval -2.18 to 0.13
|
1.7 units on a scale
Interval 0.76 to 2.63
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 21 (n=116; n=101)
|
-0.7 units on a scale
Interval -1.63 to 0.28
|
1.1 units on a scale
Interval 0.01 to 2.21
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 24 (n=95; n=82)
|
-0.8 units on a scale
Interval -1.89 to 0.38
|
2.3 units on a scale
Interval 1.13 to 3.41
|
Adverse Events
Capecitabine
Serious events: 127 serious events
Other events: 350 other events
Deaths: 0 deaths
Ixabepilone + Capecitabine
Serious events: 151 serious events
Other events: 360 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine
n=368 participants at risk
|
Ixabepilone + Capecitabine
n=369 participants at risk
|
|---|---|---|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.27%
1/368
|
0.27%
1/369
|
|
Investigations
GRIP STRENGTH DECREASED
|
0.00%
0/368
|
0.27%
1/369
|
|
Investigations
PLATELET COUNT DECREASED
|
0.54%
2/368
|
0.54%
2/369
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/368
|
0.27%
1/369
|
|
Investigations
GRANULOCYTE COUNT DECREASED
|
0.00%
0/368
|
0.27%
1/369
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.27%
1/368
|
0.27%
1/369
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.27%
1/368
|
0.00%
0/369
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
VENTRICULAR DYSFUNCTION
|
0.00%
0/368
|
0.81%
3/369
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.54%
2/368
|
0.27%
1/369
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/368
|
0.27%
1/369
|
|
Cardiac disorders
ARRHYTHMIA SUPRAVENTRICULAR
|
0.00%
0/368
|
0.27%
1/369
|
|
Vascular disorders
THROMBOSIS
|
0.00%
0/368
|
0.81%
3/369
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/368
|
0.27%
1/369
|
|
Vascular disorders
HYPOTENSION
|
0.54%
2/368
|
0.81%
3/369
|
|
Vascular disorders
LYMPHOEDEMA
|
0.27%
1/368
|
0.00%
0/369
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/368
|
0.27%
1/369
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.00%
0/368
|
0.27%
1/369
|
|
Vascular disorders
POOR VENOUS ACCESS
|
0.27%
1/368
|
0.54%
2/369
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.1%
4/368
|
0.00%
0/369
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Psychiatric disorders
ANXIETY
|
0.27%
1/368
|
0.00%
0/369
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/368
|
0.27%
1/369
|
|
Psychiatric disorders
DISORIENTATION
|
0.27%
1/368
|
0.00%
0/369
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.54%
2/368
|
0.54%
2/369
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
1.1%
4/368
|
0.27%
1/369
|
|
Hepatobiliary disorders
ACUTE HEPATIC FAILURE
|
0.00%
0/368
|
0.27%
1/369
|
|
Hepatobiliary disorders
HEPATOCELLULAR DAMAGE
|
0.27%
1/368
|
0.00%
0/369
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/368
|
0.54%
2/369
|
|
Immune system disorders
TYPE IV HYPERSENSITIVITY REACTION
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
APHASIA
|
0.27%
1/368
|
0.00%
0/369
|
|
Nervous system disorders
SYNCOPE
|
0.27%
1/368
|
0.27%
1/369
|
|
Nervous system disorders
HEADACHE
|
0.27%
1/368
|
0.27%
1/369
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/368
|
1.1%
4/369
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
CONVULSION
|
0.54%
2/368
|
0.00%
0/369
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
MENTAL IMPAIRMENT
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.27%
1/368
|
0.27%
1/369
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
0.27%
1/368
|
0.27%
1/369
|
|
Nervous system disorders
INTERCOSTAL NEURALGIA
|
0.27%
1/368
|
0.00%
0/369
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/368
|
0.27%
1/369
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/368
|
0.54%
2/369
|
|
Nervous system disorders
PARESIS CRANIAL NERVE
|
0.27%
1/368
|
0.00%
0/369
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.27%
1/368
|
0.27%
1/369
|
|
Nervous system disorders
MARCHIAFAVA-BIGNAMI DISEASE
|
0.27%
1/368
|
0.00%
0/369
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.27%
1/368
|
0.81%
3/369
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/368
|
1.4%
5/369
|
|
Gastrointestinal disorders
ILEUS
|
0.27%
1/368
|
0.81%
3/369
|
|
Gastrointestinal disorders
NAUSEA
|
1.4%
5/368
|
2.2%
8/369
|
|
Gastrointestinal disorders
ASCITES
|
0.54%
2/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
COLITIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
MELAENA
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
VOMITING
|
2.2%
8/368
|
3.3%
12/369
|
|
Gastrointestinal disorders
CHEILITIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.1%
15/368
|
3.8%
14/369
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
ENTERITIS
|
0.54%
2/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
GASTRITIS
|
0.27%
1/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
STOMATITIS
|
0.27%
1/368
|
0.81%
3/369
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.54%
2/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
4/368
|
1.1%
4/369
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
GASTROINTESTINAL ULCER
|
0.00%
0/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.54%
2/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
GASTROINTESTINAL OBSTRUCTION
|
0.27%
1/368
|
0.00%
0/369
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.00%
0/368
|
0.27%
1/369
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/368
|
0.54%
2/369
|
|
Infections and infestations
SEPSIS
|
0.00%
0/368
|
1.4%
5/369
|
|
Infections and infestations
MYIASIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/368
|
0.27%
1/369
|
|
Infections and infestations
INFECTION
|
0.54%
2/368
|
0.27%
1/369
|
|
Infections and infestations
PNEUMONIA
|
0.82%
3/368
|
4.6%
17/369
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/368
|
0.81%
3/369
|
|
Infections and infestations
ERYSIPELAS
|
0.27%
1/368
|
0.27%
1/369
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/368
|
0.27%
1/369
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Infections and infestations
BACTERAEMIA
|
0.27%
1/368
|
0.00%
0/369
|
|
Infections and infestations
SEPTIC SHOCK
|
0.27%
1/368
|
0.27%
1/369
|
|
Infections and infestations
HERPES ZOSTER
|
0.54%
2/368
|
0.54%
2/369
|
|
Infections and infestations
GASTROENTERITIS
|
0.27%
1/368
|
0.54%
2/369
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Infections and infestations
PERITONEAL INFECTION
|
0.27%
1/368
|
0.00%
0/369
|
|
Infections and infestations
NEUTROPENIC INFECTION
|
0.00%
0/368
|
0.27%
1/369
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.00%
0/368
|
0.27%
1/369
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.00%
0/368
|
0.27%
1/369
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.27%
1/368
|
0.00%
0/369
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.27%
1/368
|
0.54%
2/369
|
|
Infections and infestations
GENITOURINARY TRACT INFECTION
|
0.27%
1/368
|
0.00%
0/369
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/368
|
0.27%
1/369
|
|
Renal and urinary disorders
HAEMATURIA
|
0.27%
1/368
|
0.00%
0/369
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.27%
1/368
|
0.27%
1/369
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.27%
1/368
|
0.00%
0/369
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.27%
1/368
|
0.00%
0/369
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.27%
1/368
|
0.00%
0/369
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.54%
2/368
|
0.54%
2/369
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.82%
3/368
|
2.2%
8/369
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/368
|
0.81%
3/369
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.27%
1/368
|
0.00%
0/369
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/368
|
0.81%
3/369
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.27%
1/368
|
0.27%
1/369
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/368
|
0.54%
2/369
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/368
|
0.27%
1/369
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.27%
1/368
|
0.00%
0/369
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.82%
3/368
|
3.0%
11/369
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/368
|
1.6%
6/369
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/368
|
4.9%
18/369
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.82%
3/368
|
0.00%
0/369
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/368
|
0.27%
1/369
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.54%
2/368
|
1.9%
7/369
|
|
Blood and lymphatic system disorders
BONE MARROW FAILURE
|
0.00%
0/368
|
0.27%
1/369
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.1%
4/368
|
4.1%
15/369
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.00%
0/368
|
0.27%
1/369
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/368
|
0.27%
1/369
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.27%
1/368
|
0.00%
0/369
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/368
|
0.27%
1/369
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.27%
1/368
|
1.4%
5/369
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.27%
1/368
|
0.00%
0/369
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/368
|
0.54%
2/369
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.27%
1/368
|
0.00%
0/369
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.27%
1/368
|
0.00%
0/369
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.27%
1/368
|
0.27%
1/369
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.27%
1/368
|
0.00%
0/369
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
0.00%
0/368
|
0.27%
1/369
|
|
Injury, poisoning and procedural complications
POST LUMBAR PUNCTURE SYNDROME
|
0.27%
1/368
|
0.00%
0/369
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/368
|
0.81%
3/369
|
|
Musculoskeletal and connective tissue disorders
TRISMUS
|
0.00%
0/368
|
0.27%
1/369
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.27%
1/368
|
0.27%
1/369
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.82%
3/368
|
0.27%
1/369
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.27%
1/368
|
0.27%
1/369
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/368
|
0.27%
1/369
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.27%
1/368
|
0.54%
2/369
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.27%
1/368
|
0.00%
0/369
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.27%
1/368
|
0.27%
1/369
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/368
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.9%
7/368
|
3.8%
14/369
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/368
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
HYDROTHORAX
|
0.27%
1/368
|
0.00%
0/369
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.1%
4/368
|
0.00%
0/369
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.27%
1/368
|
0.54%
2/369
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/368
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.27%
1/368
|
0.00%
0/369
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.4%
9/368
|
1.6%
6/369
|
|
Respiratory, thoracic and mediastinal disorders
HYDROPNEUMOTHORAX
|
0.27%
1/368
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.27%
1/368
|
0.54%
2/369
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.27%
1/368
|
1.1%
4/369
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.27%
1/368
|
0.00%
0/369
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/368
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/368
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.27%
1/368
|
0.00%
0/369
|
|
General disorders
PAIN
|
0.00%
0/368
|
0.54%
2/369
|
|
General disorders
DEATH
|
0.27%
1/368
|
0.54%
2/369
|
|
General disorders
CHILLS
|
0.00%
0/368
|
0.27%
1/369
|
|
General disorders
FATIGUE
|
0.27%
1/368
|
0.81%
3/369
|
|
General disorders
PYREXIA
|
0.82%
3/368
|
2.4%
9/369
|
|
General disorders
ASTHENIA
|
0.54%
2/368
|
0.81%
3/369
|
|
General disorders
CHEST PAIN
|
0.27%
1/368
|
0.27%
1/369
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/368
|
0.27%
1/369
|
|
General disorders
GENERALISED OEDEMA
|
0.27%
1/368
|
0.00%
0/369
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.82%
3/368
|
1.1%
4/369
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.00%
0/368
|
0.27%
1/369
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.27%
1/368
|
0.27%
1/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.27%
1/368
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.27%
1/368
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
|
0.27%
1/368
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.27%
1/368
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INFECTED NEOPLASM
|
0.00%
0/368
|
0.27%
1/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT ASCITES
|
0.27%
1/368
|
0.27%
1/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.00%
0/368
|
0.27%
1/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.27%
1/368
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.54%
2/368
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
0.00%
0/368
|
0.27%
1/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.54%
2/368
|
0.54%
2/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
9.8%
36/368
|
5.1%
19/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERICARDIAL EFFUSION MALIGNANT
|
1.1%
4/368
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
2.2%
8/368
|
1.9%
7/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA STAGE UNSPECIFIED
|
0.27%
1/368
|
0.00%
0/369
|
Other adverse events
| Measure |
Capecitabine
n=368 participants at risk
|
Ixabepilone + Capecitabine
n=369 participants at risk
|
|---|---|---|
|
Eye disorders
LACRIMATION INCREASED
|
5.7%
21/368
|
5.7%
21/369
|
|
Investigations
WEIGHT DECREASED
|
11.7%
43/368
|
23.8%
88/369
|
|
Investigations
HAEMOGLOBIN DECREASED
|
1.1%
4/368
|
5.7%
21/369
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
1.6%
6/368
|
7.3%
27/369
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.82%
3/368
|
6.2%
23/369
|
|
Psychiatric disorders
INSOMNIA
|
6.8%
25/368
|
16.5%
61/369
|
|
Nervous system disorders
HEADACHE
|
11.1%
41/368
|
17.1%
63/369
|
|
Nervous system disorders
DIZZINESS
|
9.8%
36/368
|
13.0%
48/369
|
|
Nervous system disorders
DYSGEUSIA
|
3.8%
14/368
|
11.4%
42/369
|
|
Nervous system disorders
PARAESTHESIA
|
6.0%
22/368
|
19.2%
71/369
|
|
Nervous system disorders
HYPOAESTHESIA
|
2.4%
9/368
|
7.9%
29/369
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
1.4%
5/368
|
7.9%
29/369
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
2.2%
8/368
|
18.4%
68/369
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
8.2%
30/368
|
37.7%
139/369
|
|
Gastrointestinal disorders
NAUSEA
|
44.6%
164/368
|
56.6%
209/369
|
|
Gastrointestinal disorders
VOMITING
|
28.8%
106/368
|
42.8%
158/369
|
|
Gastrointestinal disorders
DIARRHOEA
|
39.9%
147/368
|
48.5%
179/369
|
|
Gastrointestinal disorders
DYSPEPSIA
|
9.5%
35/368
|
9.2%
34/369
|
|
Gastrointestinal disorders
STOMATITIS
|
10.6%
39/368
|
16.5%
61/369
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.5%
57/368
|
32.5%
120/369
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
13.9%
51/368
|
18.4%
68/369
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
3.3%
12/368
|
5.1%
19/369
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.4%
31/368
|
12.2%
45/369
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.3%
16/368
|
6.2%
23/369
|
|
Metabolism and nutrition disorders
ANOREXIA
|
18.8%
69/368
|
34.4%
127/369
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.2%
8/368
|
5.7%
21/369
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.7%
10/368
|
5.1%
19/369
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.27%
1/368
|
6.0%
22/369
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.4%
9/368
|
13.8%
51/369
|
|
Skin and subcutaneous tissue disorders
RASH
|
7.3%
27/368
|
12.2%
45/369
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
4.3%
16/368
|
32.8%
121/369
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.8%
25/368
|
6.2%
23/369
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
4.6%
17/368
|
6.8%
25/369
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.1%
15/368
|
5.7%
21/369
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
9.8%
36/368
|
20.6%
76/369
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
14.4%
53/368
|
11.1%
41/369
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
62.0%
228/368
|
63.7%
235/369
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.5%
24/368
|
35.2%
130/369
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.4%
53/368
|
12.5%
46/369
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
5.2%
19/368
|
7.0%
26/369
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.8%
25/368
|
23.6%
87/369
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.2%
30/368
|
19.0%
70/369
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
4.3%
16/368
|
11.1%
41/369
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.4%
20/368
|
5.4%
20/369
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.0%
59/368
|
19.8%
73/369
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.2%
67/368
|
16.5%
61/369
|
|
General disorders
PAIN
|
2.2%
8/368
|
7.3%
27/369
|
|
General disorders
FATIGUE
|
26.4%
97/368
|
43.4%
160/369
|
|
General disorders
PYREXIA
|
12.8%
47/368
|
15.2%
56/369
|
|
General disorders
ASTHENIA
|
15.5%
57/368
|
27.4%
101/369
|
|
General disorders
CHEST PAIN
|
5.2%
19/368
|
6.0%
22/369
|
|
General disorders
OEDEMA PERIPHERAL
|
12.5%
46/368
|
13.8%
51/369
|
|
General disorders
MUCOSAL INFLAMMATION
|
10.6%
39/368
|
16.0%
59/369
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER