Trial Outcomes & Findings for Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer (NCT NCT00082433)
NCT ID: NCT00082433
Last Updated: 2020-11-02
Results Overview
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1221 participants
Primary outcome timeframe
from date of randomization until death
Results posted on
2020-11-02
Participant Flow
PLEASE NOTE: Completed=number of participants completing ≥18 cycles of treatment; not completed=number of subjects coming off study treatment prior to completing at least 18 cycles, with specified reasons for coming off study treatment. Participants continued to be followed for overall survival.
Participant milestones
| Measure |
Ixabepilone + Capecitabine
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Overall Study
STARTED
|
609
|
612
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
594
|
597
|
Reasons for withdrawal
| Measure |
Ixabepilone + Capecitabine
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
17
|
|
Overall Study
Death
|
8
|
18
|
|
Overall Study
Disease Progression/Relapse
|
270
|
388
|
|
Overall Study
Physician Decision
|
50
|
61
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Study Drug Toxicity
|
179
|
66
|
|
Overall Study
Withdrawal by Subject
|
55
|
30
|
|
Overall Study
Still On Treatment
|
2
|
1
|
|
Overall Study
Not Treated
|
12
|
11
|
|
Overall Study
Ineligible
|
2
|
1
|
|
Overall Study
Noncompliance
|
2
|
1
|
|
Overall Study
New primary cancer
|
1
|
0
|
|
Overall Study
Impending surgery
|
0
|
1
|
Baseline Characteristics
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone + Capecitabine
n=609 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=612 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Total
n=1221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
532 participants
n=5 Participants
|
531 participants
n=7 Participants
|
1063 participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
77 participants
n=5 Participants
|
81 participants
n=7 Participants
|
158 participants
n=5 Participants
|
|
Age, Customized
<50 years
|
225 participants
n=5 Participants
|
235 participants
n=7 Participants
|
460 participants
n=5 Participants
|
|
Age, Customized
≥50 years
|
384 participants
n=5 Participants
|
377 participants
n=7 Participants
|
761 participants
n=5 Participants
|
|
Age, Continuous
|
53.0 years
n=5 Participants
|
53.0 years
n=7 Participants
|
53.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
609 Participants
n=5 Participants
|
612 Participants
n=7 Participants
|
1221 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
90 participants
n=5 Participants
|
69 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
480 participants
n=5 Participants
|
502 participants
n=7 Participants
|
982 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
13 participants
n=5 Participants
|
18 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Karnofsky performance Status
100
|
219 units on a scale
n=5 Participants
|
265 units on a scale
n=7 Participants
|
484 units on a scale
n=5 Participants
|
|
Karnofsky performance Status
90
|
187 units on a scale
n=5 Participants
|
188 units on a scale
n=7 Participants
|
375 units on a scale
n=5 Participants
|
|
Karnofsky performance Status
80
|
151 units on a scale
n=5 Participants
|
130 units on a scale
n=7 Participants
|
281 units on a scale
n=5 Participants
|
|
Karnofsky performance Status
70
|
44 units on a scale
n=5 Participants
|
26 units on a scale
n=7 Participants
|
70 units on a scale
n=5 Participants
|
|
Karnofsky performance Status
<70
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
|
Karnofsky performance Status
not reported
|
6 units on a scale
n=5 Participants
|
1 units on a scale
n=7 Participants
|
7 units on a scale
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
93 participants
n=5 Participants
|
90 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Menopausal Status
Perimenopausal
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
475 participants
n=5 Participants
|
481 participants
n=7 Participants
|
956 participants
n=5 Participants
|
|
Menopausal Status
Not Reported
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Organ Sites
Ascites
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Organ Sites
Bone
|
283 participants
n=5 Participants
|
287 participants
n=7 Participants
|
570 participants
n=5 Participants
|
|
Organ Sites
Brain
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Organ Sites
Breast
|
41 participants
n=5 Participants
|
54 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Organ Sites
Chest Wall Mass
|
47 participants
n=5 Participants
|
38 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Organ Sites
CNS
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Organ Sites
Cutaneous
|
64 participants
n=5 Participants
|
57 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Organ Sites
Effusion
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Organ Sites
Intestine
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Organ Sites
Lymph Node
|
236 participants
n=5 Participants
|
233 participants
n=7 Participants
|
469 participants
n=5 Participants
|
|
Organ Sites
Mediastinum
|
54 participants
n=5 Participants
|
52 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Organ Sites
Other
|
17 participants
n=5 Participants
|
30 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Organ Sites
Pleura
|
86 participants
n=5 Participants
|
84 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
Organ Sites
Subcutaneous
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Organ Sites
Visceral, Liver
|
273 participants
n=5 Participants
|
276 participants
n=7 Participants
|
549 participants
n=5 Participants
|
|
Organ Sites
Visceral, Lung
|
221 participants
n=5 Participants
|
217 participants
n=7 Participants
|
438 participants
n=5 Participants
|
|
Organ Sites
Visceral, Other
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Presence with at least 1 lesion
|
606 participants
n=5 Participants
|
612 participants
n=7 Participants
|
1218 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from date of randomization until deathPopulation: Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=609 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=612 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Overall Survival (OS)
|
16.39 months
Interval 14.95 to 17.91
|
15.64 months
Interval 13.86 to 17.02
|
SECONDARY outcome
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progressionPopulation: All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants.
PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=480 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=480 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
6.24 months
Interval 5.59 to 6.77
|
4.40 months
Interval 4.14 to 5.42
|
SECONDARY outcome
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progressionPopulation: Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline).
RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=462 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=462 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Response Rate (RR)
|
43.3 percentage of participants
Interval 38.7 to 47.9
|
28.8 percentage of participants
Interval 24.7 to 33.2
|
SECONDARY outcome
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progressionPopulation: Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)
Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=200 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=133 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Duration of Response
|
6.1 Months
Interval 5.5 to 7.0
|
6.3 Months
Interval 5.3 to 7.6
|
SECONDARY outcome
Timeframe: every 6 weeks (± 3 days) from randomization while on treatment until documented progressionPopulation: Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)
Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).
Outcome measures
| Measure |
Ixabepilone + Capecitabine
n=200 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=133 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Time to Response
|
6.6 weeks
Interval 4.7 to 47.9
|
6.6 weeks
Interval 4.6 to 59.4
|
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 patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046.
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=595 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=603 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Treatment-Related Safety Summary
Deaths within 30 days of last dose
|
19 Participants
|
42 Participants
|
|
Treatment-Related Safety Summary
Treatment-related serious adverse events
|
125 Participants
|
64 Participants
|
|
Treatment-Related Safety Summary
Treatment-related Grade 3-4 adverse events
|
458 Participants
|
240 Participants
|
|
Treatment-Related Safety Summary
Treatment-related AEs leading to discontinuation
|
286 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessmentPopulation: 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=609 Participants
Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
Capecitabine
n=612 Participants
Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
|
|---|---|---|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 15 (n=255; n=240)
|
-1.9 units on a scale
95% Confidence Interval 17.0 • Interval -2.73 to -1.15
|
1.5 units on a scale
95% Confidence Interval 5.0 • Interval 0.9 to 2.18
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 3 (n=440; n=429)
|
-0.5 units on a scale
95% Confidence Interval 13.7 • Interval -0.96 to 0.2
|
0.0 units on a scale
95% Confidence Interval 4.7 • Interval -0.44 to 0.45
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 6 (n=379; n=353)
|
-0.9 units on a scale
95% Confidence Interval 15.4 • Interval -1.45 to -0.31
|
0.5 units on a scale
95% Confidence Interval 5.0 • Interval 0.02 to 1.06
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 9 (n=330; n=283)
|
-1.5 units on a scale
95% Confidence Interval 17.4 • Interval -2.15 to -0.79
|
0.7 units on a scale
95% Confidence Interval 5.0 • Interval 0.06 to 1.24
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 12 (n=283; n=250)
|
-1.4 units on a scale
95% Confidence Interval 17.3 • Interval -2.06 to -0.64
|
1.1 units on a scale
95% Confidence Interval 5.2 • Interval 0.48 to 1.78
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 18 (n=205; n=202)
|
-1.3 units on a scale
95% Confidence Interval 15.7 • Interval -2.07 to -0.5
|
1.2 units on a scale
95% Confidence Interval 5.4 • Interval 0.41 to 1.89
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 21 (n=166; n=185)
|
-1.4 units on a scale
95% Confidence Interval 16.8 • Interval -2.36 to -0.37
|
1.7 units on a scale
95% Confidence Interval 5.1 • Interval 0.97 to 2.45
|
|
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Week 24 (n=149; n=141)
|
-1.4 units on a scale
95% Confidence Interval 17.3 • Interval -2.46 to -0.41
|
1.1 units on a scale
95% Confidence Interval 5.4 • Interval 0.19 to 1.96
|
Adverse Events
Capecitabine
Serious events: 192 serious events
Other events: 564 other events
Deaths: 0 deaths
Ixabepilone + Capecitabine
Serious events: 205 serious events
Other events: 590 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine
n=603 participants at risk
|
Ixabepilone + Capecitabine
n=595 participants at risk
|
|---|---|---|
|
Eye disorders
EYE PAIN
|
0.17%
1/603
|
0.00%
0/595
|
|
Eye disorders
ECTROPION
|
0.00%
0/603
|
0.17%
1/595
|
|
Eye disorders
EYELID PTOSIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Eye disorders
VISUAL DISTURBANCE
|
0.00%
0/603
|
0.17%
1/595
|
|
Eye disorders
BLINDNESS UNILATERAL
|
0.00%
0/603
|
0.17%
1/595
|
|
Eye disorders
ULCERATIVE KERATITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Investigations
DIAGNOSTIC PROCEDURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/603
|
0.17%
1/595
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
0.00%
0/603
|
0.17%
1/595
|
|
Investigations
PLATELET COUNT DECREASED
|
0.33%
2/603
|
0.34%
2/595
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
0.00%
0/603
|
0.17%
1/595
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/603
|
0.50%
3/595
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
0.17%
1/603
|
0.00%
0/595
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/603
|
0.50%
3/595
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.33%
2/603
|
0.00%
0/595
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.17%
1/603
|
0.17%
1/595
|
|
Cardiac disorders
PERICARDITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/603
|
0.17%
1/595
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/603
|
0.17%
1/595
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/603
|
0.34%
2/595
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.33%
2/603
|
0.00%
0/595
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.66%
4/603
|
0.00%
0/595
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.17%
1/603
|
0.00%
0/595
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.17%
1/603
|
0.17%
1/595
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/603
|
0.17%
1/595
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.17%
1/603
|
0.00%
0/595
|
|
Vascular disorders
SHOCK
|
0.17%
1/603
|
0.00%
0/595
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/603
|
0.17%
1/595
|
|
Vascular disorders
THROMBOSIS
|
0.33%
2/603
|
0.34%
2/595
|
|
Vascular disorders
HYPOTENSION
|
0.17%
1/603
|
0.67%
4/595
|
|
Vascular disorders
LYMPHOEDEMA
|
0.17%
1/603
|
0.00%
0/595
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/603
|
0.17%
1/595
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.00%
0/603
|
0.17%
1/595
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.00%
6/603
|
0.50%
3/595
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
0.17%
1/603
|
0.00%
0/595
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.17%
1/603
|
0.00%
0/595
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.66%
4/603
|
0.34%
2/595
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.17%
1/603
|
0.00%
0/595
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.50%
3/603
|
0.34%
2/595
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.17%
1/603
|
0.00%
0/595
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.33%
2/603
|
0.00%
0/595
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
0.00%
0/603
|
0.17%
1/595
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/603
|
0.67%
4/595
|
|
Nervous system disorders
ATAXIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Nervous system disorders
SYNCOPE
|
0.17%
1/603
|
0.17%
1/595
|
|
Nervous system disorders
DYSTONIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
HEADACHE
|
0.50%
3/603
|
0.34%
2/595
|
|
Nervous system disorders
DIZZINESS
|
1.00%
6/603
|
0.00%
0/595
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/603
|
0.34%
2/595
|
|
Nervous system disorders
MONOPLEGIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Nervous system disorders
SOMNOLENCE
|
0.17%
1/603
|
0.00%
0/595
|
|
Nervous system disorders
HEMIPARESIS
|
0.17%
1/603
|
0.17%
1/595
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.17%
1/603
|
0.00%
0/595
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.17%
1/603
|
0.17%
1/595
|
|
Nervous system disorders
AUTONOMIC NEUROPATHY
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.17%
1/603
|
0.50%
3/595
|
|
Nervous system disorders
DEMYELINATING POLYNEUROPATHY
|
0.00%
0/603
|
0.17%
1/595
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/603
|
1.0%
6/595
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/603
|
0.17%
1/595
|
|
Gastrointestinal disorders
ILEUS
|
0.17%
1/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
NAUSEA
|
1.2%
7/603
|
2.0%
12/595
|
|
Gastrointestinal disorders
ASCITES
|
0.17%
1/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
COLITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
VOMITING
|
2.8%
17/603
|
4.0%
24/595
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.5%
33/603
|
3.9%
23/595
|
|
Gastrointestinal disorders
GASTRITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
STOMATITIS
|
0.33%
2/603
|
0.84%
5/595
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.33%
2/603
|
1.0%
6/595
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/603
|
0.17%
1/595
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/603
|
0.34%
2/595
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.50%
3/603
|
1.2%
7/595
|
|
Gastrointestinal disorders
PANCREATIC CYST
|
0.17%
1/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.17%
1/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.00%
0/603
|
0.17%
1/595
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.17%
1/603
|
0.17%
1/595
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.17%
1/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.33%
2/603
|
0.00%
0/595
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.17%
1/603
|
0.00%
0/595
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
SEPSIS
|
0.50%
3/603
|
1.0%
6/595
|
|
Infections and infestations
EMPYEMA
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
CYSTITIS
|
0.17%
1/603
|
0.17%
1/595
|
|
Infections and infestations
INFECTION
|
0.66%
4/603
|
0.67%
4/595
|
|
Infections and infestations
PNEUMONIA
|
0.83%
5/603
|
1.0%
6/595
|
|
Infections and infestations
CELLULITIS
|
0.17%
1/603
|
0.50%
3/595
|
|
Infections and infestations
ERYSIPELAS
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
MENINGITIS
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
ABSCESS LIMB
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
LYMPHANGITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
SEPTIC SHOCK
|
0.17%
1/603
|
0.34%
2/595
|
|
Infections and infestations
TUBERCULOSIS
|
0.17%
1/603
|
0.17%
1/595
|
|
Infections and infestations
FUNGAL SEPSIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
GASTROENTERITIS
|
0.33%
2/603
|
0.17%
1/595
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
WOUND INFECTION
|
0.50%
3/603
|
0.17%
1/595
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
VAGINAL CELLULITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
ANORECTAL INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
NEUTROPENIC INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
0.50%
3/603
|
0.67%
4/595
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
GASTROENTERITIS NORWALK VIRUS
|
0.17%
1/603
|
0.00%
0/595
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.17%
1/603
|
0.34%
2/595
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Renal and urinary disorders
OLIGURIA
|
0.00%
0/603
|
0.17%
1/595
|
|
Renal and urinary disorders
RENAL ATROPHY
|
0.17%
1/603
|
0.00%
0/595
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.50%
3/603
|
0.00%
0/595
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.17%
1/603
|
0.00%
0/595
|
|
Renal and urinary disorders
CYSTITIS HAEMORRHAGIC
|
0.00%
0/603
|
0.17%
1/595
|
|
Surgical and medical procedures
CATHETER PLACEMENT
|
0.17%
1/603
|
0.00%
0/595
|
|
Surgical and medical procedures
CENTRAL VENOUS CATHETERISATION
|
0.00%
0/603
|
0.50%
3/595
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.83%
5/603
|
0.34%
2/595
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.2%
7/603
|
1.2%
7/595
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.17%
1/603
|
0.34%
2/595
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.17%
1/603
|
0.17%
1/595
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.17%
1/603
|
0.17%
1/595
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.83%
5/603
|
1.2%
7/595
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.17%
1/603
|
1.3%
8/595
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.3%
8/603
|
3.0%
18/595
|
|
Blood and lymphatic system disorders
LYMPH NODE PAIN
|
0.00%
0/603
|
0.17%
1/595
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.50%
3/603
|
0.67%
4/595
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.83%
5/603
|
5.7%
34/595
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.17%
1/603
|
0.50%
3/595
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.17%
1/603
|
0.00%
0/595
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
SWELLING FACE
|
0.17%
1/603
|
0.00%
0/595
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.00%
0/603
|
0.34%
2/595
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
DERMATITIS EXFOLIATIVE
|
0.00%
0/603
|
0.17%
1/595
|
|
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME
|
0.17%
1/603
|
0.00%
0/595
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.50%
3/603
|
0.84%
5/595
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/603
|
0.17%
1/595
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.17%
1/603
|
0.67%
4/595
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.17%
1/603
|
1.2%
7/595
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.17%
1/603
|
0.00%
0/595
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/603
|
0.17%
1/595
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/603
|
0.50%
3/595
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/603
|
0.17%
1/595
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/603
|
0.17%
1/595
|
|
Injury, poisoning and procedural complications
PUBIC RAMI FRACTURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Injury, poisoning and procedural complications
TRACHEAL OBSTRUCTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.00%
0/603
|
0.17%
1/595
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.00%
0/603
|
0.17%
1/595
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.17%
1/603
|
0.34%
2/595
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.33%
2/603
|
0.17%
1/595
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.66%
4/603
|
0.50%
3/595
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.33%
2/603
|
0.50%
3/595
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.17%
1/603
|
0.00%
0/595
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/603
|
0.17%
1/595
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.17%
1/603
|
0.34%
2/595
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.33%
2/603
|
0.00%
0/595
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.17%
1/603
|
0.00%
0/595
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.00%
0/603
|
0.34%
2/595
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.33%
2/603
|
0.00%
0/595
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.17%
1/603
|
0.00%
0/595
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
4.1%
25/603
|
1.7%
10/595
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Respiratory, thoracic and mediastinal disorders
ALVEOLITIS
|
0.17%
1/603
|
0.00%
0/595
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/603
|
0.17%
1/595
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.17%
1/603
|
0.50%
3/595
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.33%
2/603
|
0.00%
0/595
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.17%
1/603
|
0.34%
2/595
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.2%
13/603
|
1.2%
7/595
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.33%
2/603
|
0.00%
0/595
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.50%
3/603
|
0.84%
5/595
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.50%
3/603
|
0.17%
1/595
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.17%
1/603
|
0.00%
0/595
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.17%
1/603
|
0.00%
0/595
|
|
General disorders
PAIN
|
0.33%
2/603
|
0.50%
3/595
|
|
General disorders
FATIGUE
|
1.00%
6/603
|
1.3%
8/595
|
|
General disorders
PYREXIA
|
1.3%
8/603
|
1.0%
6/595
|
|
General disorders
ASTHENIA
|
0.33%
2/603
|
0.17%
1/595
|
|
General disorders
CHEST PAIN
|
0.33%
2/603
|
0.17%
1/595
|
|
General disorders
HYPOTHERMIA
|
0.00%
0/603
|
0.17%
1/595
|
|
General disorders
SUDDEN DEATH
|
0.17%
1/603
|
0.17%
1/595
|
|
General disorders
EXTRAVASATION
|
0.00%
0/603
|
0.17%
1/595
|
|
General disorders
CATHETER THROMBOSIS
|
0.17%
1/603
|
0.00%
0/595
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/603
|
0.17%
1/595
|
|
General disorders
CATHETER SITE OEDEMA
|
0.00%
0/603
|
0.17%
1/595
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.66%
4/603
|
1.0%
6/595
|
|
General disorders
INJECTION SITE EXTRAVASATION
|
0.00%
0/603
|
0.17%
1/595
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.17%
1/603
|
0.00%
0/595
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.66%
4/603
|
0.84%
5/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.33%
2/603
|
0.50%
3/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/603
|
0.17%
1/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.17%
1/603
|
0.17%
1/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST NEOPLASM
|
0.17%
1/603
|
0.00%
0/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT ASCITES
|
0.33%
2/603
|
0.00%
0/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.17%
1/603
|
0.00%
0/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.00%
0/603
|
0.17%
1/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.00%
0/603
|
0.17%
1/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.17%
1/603
|
0.00%
0/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
1.8%
11/603
|
0.84%
5/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
7.1%
43/603
|
2.9%
17/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERICARDIAL EFFUSION MALIGNANT
|
0.17%
1/603
|
0.00%
0/595
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.66%
4/603
|
0.67%
4/595
|
Other adverse events
| Measure |
Capecitabine
n=603 participants at risk
|
Ixabepilone + Capecitabine
n=595 participants at risk
|
|---|---|---|
|
Investigations
WEIGHT DECREASED
|
17.2%
104/603
|
32.6%
194/595
|
|
Investigations
WEIGHT INCREASED
|
7.8%
47/603
|
4.4%
26/595
|
|
Investigations
HAEMOGLOBIN DECREASED
|
3.6%
22/603
|
7.4%
44/595
|
|
Investigations
PLATELET COUNT DECREASED
|
2.2%
13/603
|
5.5%
33/595
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
3.5%
21/603
|
11.3%
67/595
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
2.2%
13/603
|
7.4%
44/595
|
|
Psychiatric disorders
INSOMNIA
|
6.1%
37/603
|
14.1%
84/595
|
|
Nervous system disorders
HEADACHE
|
12.1%
73/603
|
16.3%
97/595
|
|
Nervous system disorders
DIZZINESS
|
8.3%
50/603
|
11.6%
69/595
|
|
Nervous system disorders
DYSGEUSIA
|
2.3%
14/603
|
11.3%
67/595
|
|
Nervous system disorders
HYPOREFLEXIA
|
2.8%
17/603
|
6.2%
37/595
|
|
Nervous system disorders
PARAESTHESIA
|
7.5%
45/603
|
19.3%
115/595
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
2.0%
12/603
|
7.7%
46/595
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
3.8%
23/603
|
9.4%
56/595
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
10.6%
64/603
|
43.4%
258/595
|
|
Gastrointestinal disorders
NAUSEA
|
40.3%
243/603
|
52.9%
315/595
|
|
Gastrointestinal disorders
VOMITING
|
27.9%
168/603
|
42.0%
250/595
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.5%
244/603
|
44.7%
266/595
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.5%
45/603
|
8.6%
51/595
|
|
Gastrointestinal disorders
STOMATITIS
|
11.3%
68/603
|
19.8%
118/595
|
|
Gastrointestinal disorders
CONSTIPATION
|
12.1%
73/603
|
27.1%
161/595
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
12.8%
77/603
|
14.8%
88/595
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.8%
47/603
|
9.2%
55/595
|
|
Metabolism and nutrition disorders
ANOREXIA
|
16.4%
99/603
|
30.8%
183/595
|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.3%
44/603
|
11.6%
69/595
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
4.6%
28/603
|
14.3%
85/595
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
8.1%
49/603
|
26.7%
159/595
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.1%
25/603
|
11.4%
68/595
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
3.3%
20/603
|
41.2%
245/595
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.5%
39/603
|
8.6%
51/595
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
2.0%
12/603
|
5.7%
34/595
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.8%
17/603
|
5.2%
31/595
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
12.8%
77/603
|
32.4%
193/595
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
12.4%
75/603
|
13.3%
79/595
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
68.3%
412/603
|
64.4%
383/595
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
3.6%
22/603
|
24.5%
146/595
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.3%
62/603
|
11.8%
70/595
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
7.5%
45/603
|
9.2%
55/595
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.0%
30/603
|
20.0%
119/595
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.83%
5/603
|
5.0%
30/595
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
9.3%
56/603
|
18.8%
112/595
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
6.1%
37/603
|
14.3%
85/595
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.3%
68/603
|
15.0%
89/595
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
13.9%
84/603
|
16.6%
99/595
|
|
General disorders
PAIN
|
3.3%
20/603
|
5.4%
32/595
|
|
General disorders
FATIGUE
|
27.5%
166/603
|
45.7%
272/595
|
|
General disorders
PYREXIA
|
10.9%
66/603
|
14.1%
84/595
|
|
General disorders
ASTHENIA
|
11.9%
72/603
|
21.5%
128/595
|
|
General disorders
OEDEMA PERIPHERAL
|
7.1%
43/603
|
10.6%
63/595
|
|
General disorders
MUCOSAL INFLAMMATION
|
8.8%
53/603
|
13.3%
79/595
|
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