A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00089479
Collaborator
(none)
2,611
1
2
117
22.3
Study Details
Study Description
Brief Summary
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2611 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer
Study Start Date
:
Aug 1, 2002
Actual Primary Completion Date
:
Jun 1, 2010
Actual Study Completion Date
:
May 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle
Drug: Taxotere
75mg/m2 iv on day 1 of each 3 week cycle
|
| Active Comparator: 2
|
Drug: Taxotere
100mg/m2 iv on day 1 of each 3 week cycle
|
Outcome Measures
Primary Outcome Measures
- Disease Free Survival [Number of Events] [Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.]
Number of patients with/without recurrence of breast cancer, or death due to any cause.
- Disease Free Survival [Time to Event] [Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.]
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Secondary Outcome Measures
- Overall Survival [Number of Events] [Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.]
Number of patients who died/were alive.
- Overall Survival [Time to Event] [Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.]
Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.
- Breast Cancer Free Survival [Number of Events] [Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
- Breast Cancer Free Survival [Time to Event] [Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.]
Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
- Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] [Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
- Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event [Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.]
Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
- Disease Free Survival Including Any New Cancer as Event [Number of Events] [Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.]
Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
- Disease Free Survival Including Any New Cancer as Event [Time to Event] [Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.]
Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
female patients 18-70 years of age;
-
adenocarcinoma of the breast;
-
previous invasive breast cancer if diagnosed >5 years before entering study;
-
no evidence of metastatic disease.
Exclusion Criteria:
-
history of severe hypersensitivity reaction to Taxotere;
-
previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;
-
treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Houston | Texas | United States | 77060 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00089479
Other Study ID Numbers:
- NO17629
First Posted:
Aug 6, 2004
Last Update Posted:
Dec 21, 2012
Last Verified:
Dec 1, 2012
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Period Title: Overall Study | ||
| STARTED | 1304 | 1307 |
| Received Treatment | 1305 | 1283 |
| COMPLETED | 973 | 1018 |
| NOT COMPLETED | 331 | 289 |
Baseline Characteristics
| Arm/Group Title | AC Then T | AC Then XT | Total |
|---|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles | Total of all reporting groups |
| Overall Participants | 1304 | 1307 | 2611 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.2
(8.81)
|
50.6
(9.19)
|
50.9
(9.00)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1304
100%
|
1307
100%
|
2611
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Disease Free Survival [Number of Events] |
|---|---|
| Description | Number of patients with/without recurrence of breast cancer, or death due to any cause. |
| Time Frame | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Patients with event |
164
12.6%
|
140
10.7%
|
| Patients without events |
1140
87.4%
|
1167
89.3%
|
| Title | Overall Survival [Number of Events] |
|---|---|
| Description | Number of patients who died/were alive. |
| Time Frame | Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Patients with event |
108
8.3%
|
75
5.7%
|
| Patients without events |
1196
91.7%
|
1232
94.3%
|
| Title | Disease Free Survival [Time to Event] |
|---|---|
| Description | Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. |
| Time Frame | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Median (95% Confidence Interval) [months] |
NA
|
NA
|
| Title | Overall Survival [Time to Event] |
|---|---|
| Description | Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive. |
| Time Frame | Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Median (95% Confidence Interval) [months] |
NA
|
NA
|
| Title | Breast Cancer Free Survival [Number of Events] |
|---|---|
| Description | Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. |
| Time Frame | Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years . |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Patients with event |
158
12.1%
|
144
11%
|
| Patients without events |
1146
87.9%
|
1163
89%
|
| Title | Breast Cancer Free Survival [Time to Event] |
|---|---|
| Description | Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. |
| Time Frame | Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Median (95% Confidence Interval) [months] |
NA
|
NA
|
| Title | Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] |
|---|---|
| Description | Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause. |
| Time Frame | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Patients with event |
169
13%
|
154
11.8%
|
| Patients without events |
1135
87%
|
1153
88.2%
|
| Title | Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event |
|---|---|
| Description | Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. |
| Time Frame | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Median (95% Confidence Interval) [months] |
NA
|
NA
|
| Title | Disease Free Survival Including Any New Cancer as Event [Number of Events] |
|---|---|
| Description | Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause. |
| Time Frame | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Patients with event |
200
15.3%
|
177
13.5%
|
| Patients without events |
1104
84.7%
|
1130
86.5%
|
| Title | Disease Free Survival Including Any New Cancer as Event [Time to Event] |
|---|---|
| Description | Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free. |
| Time Frame | Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | AC Then T | AC Then XT |
|---|---|---|
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles |
| Measure Participants | 1304 | 1307 |
| Median (95% Confidence Interval) [months] |
NA
|
NA
|
Adverse Events
| Time Frame | Length of study | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Analysis Population: Patients are assigned to treatment groups based on the treatment (T or XT) they received, patients who did not receive T or X were assigned to the treatment groups as randomized. AE summaries display AEs that occurred during the period 1st study treatment intake (AC) until 30 days after last study treatment intake. | |||
| Arm/Group Title | AC Then T | AC Then XT | ||
| Arm/Group Description | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles | Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles | ||
All Cause Mortality |
||||
| AC Then T | AC Then XT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| AC Then T | AC Then XT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 264/1305 (20.2%) | 200/1283 (15.6%) | ||
| Blood and lymphatic system disorders | ||||
| FEBRILE NEUTROPENIA | 118/1305 (9%) | 80/1283 (6.2%) | ||
| NEUTROPENIA | 10/1305 (0.8%) | 11/1283 (0.9%) | ||
| ANAEMIA | 0/1305 (0%) | 5/1283 (0.4%) | ||
| LEUKOCYTOSIS | 2/1305 (0.2%) | 0/1283 (0%) | ||
| LEUKOPENIA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| PANCYTOPENIA | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Cardiac disorders | ||||
| MYOCARDIAL INFARCTION | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| SUPRAVENTRICULAR TACHYCARDIA | 2/1305 (0.2%) | 0/1283 (0%) | ||
| ANGINA UNSTABLE | 0/1305 (0%) | 1/1283 (0.1%) | ||
| ATRIAL FLUTTER | 0/1305 (0%) | 1/1283 (0.1%) | ||
| CARDIAC FAILURE CONGESTIVE | 0/1305 (0%) | 1/1283 (0.1%) | ||
| CARDIOMYOPATHY | 1/1305 (0.1%) | 0/1283 (0%) | ||
| CARDIOMYOPATHY ACUTE | 0/1305 (0%) | 1/1283 (0.1%) | ||
| LEFT VENTRICULAR DYSFUNCTION | 0/1305 (0%) | 1/1283 (0.1%) | ||
| PALPITATIONS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| TACHYCARDIA | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Ear and labyrinth disorders | ||||
| VERTIGO | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Gastrointestinal disorders | ||||
| VOMITING | 13/1305 (1%) | 5/1283 (0.4%) | ||
| DIARRHOEA | 10/1305 (0.8%) | 4/1283 (0.3%) | ||
| NAUSEA | 7/1305 (0.5%) | 6/1283 (0.5%) | ||
| STOMATITIS ALL | 4/1305 (0.3%) | 6/1283 (0.5%) | ||
| ABDOMINAL PAIN | 5/1305 (0.4%) | 2/1283 (0.2%) | ||
| COLITIS | 3/1305 (0.2%) | 2/1283 (0.2%) | ||
| CONSTIPATION | 3/1305 (0.2%) | 0/1283 (0%) | ||
| GASTRITIS | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| SMALL INTESTINAL OBSTRUCTION | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| ENTEROCUTANEOUS FISTULA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| GASTRITIS EROSIVE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| GASTROINTESTINAL HAEMORRHAGE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| HAEMORRHOIDS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| ILEUS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| OESOPHAGITIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| OESOPHAGITIS ULCERATIVE | 0/1305 (0%) | 1/1283 (0.1%) | ||
| PANCREATITIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| RECTAL HAEMORRHAGE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| General disorders | ||||
| PYREXIA | 21/1305 (1.6%) | 9/1283 (0.7%) | ||
| CHEST PAIN | 5/1305 (0.4%) | 11/1283 (0.9%) | ||
| ASTHENIA | 2/1305 (0.2%) | 2/1283 (0.2%) | ||
| FATIGUE | 2/1305 (0.2%) | 1/1283 (0.1%) | ||
| HERNIA OBSTRUCTIVE | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| NON-CARDIAC CHEST PAIN | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| THROMBOSIS IN DEVICE | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| CATHETER SITE PAIN | 1/1305 (0.1%) | 0/1283 (0%) | ||
| CHEST DISCOMFORT | 1/1305 (0.1%) | 0/1283 (0%) | ||
| DEVICE DISLOCATION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| MEDICAL DEVICE COMPLICATION | 0/1305 (0%) | 1/1283 (0.1%) | ||
| OEDEMA PERIPHERAL | 0/1305 (0%) | 1/1283 (0.1%) | ||
| PAIN | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Hepatobiliary disorders | ||||
| CHOLECYSTITIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| CHOLELITHIASIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Immune system disorders | ||||
| HYPERSENSITIVITY | 0/1305 (0%) | 2/1283 (0.2%) | ||
| DRUG HYPERSENSITIVITY | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Infections and infestations | ||||
| CELLULITIS | 11/1305 (0.8%) | 6/1283 (0.5%) | ||
| PNEUMONIA | 10/1305 (0.8%) | 4/1283 (0.3%) | ||
| SEPSIS | 5/1305 (0.4%) | 3/1283 (0.2%) | ||
| INFECTION | 4/1305 (0.3%) | 3/1283 (0.2%) | ||
| DEVICE RELATED INFECTION | 4/1305 (0.3%) | 1/1283 (0.1%) | ||
| NEUTROPENIC INFECTION | 2/1305 (0.2%) | 3/1283 (0.2%) | ||
| BREAST CELLULITIS | 2/1305 (0.2%) | 2/1283 (0.2%) | ||
| BREAST INFECTION | 2/1305 (0.2%) | 2/1283 (0.2%) | ||
| BRONCHITIS | 2/1305 (0.2%) | 2/1283 (0.2%) | ||
| NEUTROPENIC SEPSIS | 2/1305 (0.2%) | 1/1283 (0.1%) | ||
| URINARY TRACT INFECTION | 2/1305 (0.2%) | 1/1283 (0.1%) | ||
| WOUND INFECTION | 1/1305 (0.1%) | 2/1283 (0.2%) | ||
| BREAST ABSCESS | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| GASTROENTERITIS | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| SINUSITIS | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| STAPHYLOCOCCAL INFECTION | 2/1305 (0.2%) | 0/1283 (0%) | ||
| UPPER RESPIRATORY TRACT INFECTION | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| ABSCESS LIMB | 1/1305 (0.1%) | 0/1283 (0%) | ||
| ACUTE SINUSITIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| APPENDICITIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| BACTERIAL SEPSIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| CLOSTRIDIAL INFECTION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| DEVICE RELATED SEPSIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| DIVERTICULITIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| FEBRILE INFECTION | 0/1305 (0%) | 1/1283 (0.1%) | ||
| FUNGAL SKIN INFECTION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| GASTROENTERITIS VIRAL | 0/1305 (0%) | 1/1283 (0.1%) | ||
| HISTOPLASMOSIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| MASTITIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| MENINGITIS BACTERIAL | 1/1305 (0.1%) | 0/1283 (0%) | ||
| ORAL CANDIDIASIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| ORAL HERPES | 1/1305 (0.1%) | 0/1283 (0%) | ||
| OTITIS MEDIA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| PAROTITIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| PERIDIVERTICULAR ABSCESS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| PHARYNGITIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| PLEURAL INFECTION | 0/1305 (0%) | 1/1283 (0.1%) | ||
| PNEUMONIA PRIMARY ATYPICAL | 0/1305 (0%) | 1/1283 (0.1%) | ||
| SOFT TISSUE INFECTION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| TOOTH ABSCESS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| VIRAL UPPER RESPIRATORY TRACT INFECTION | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| ANKLE FRACTURE | 2/1305 (0.2%) | 1/1283 (0.1%) | ||
| ARTHROPOD BITE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| COMPRESSION FRACTURE | 0/1305 (0%) | 1/1283 (0.1%) | ||
| HIP FRACTURE | 0/1305 (0%) | 1/1283 (0.1%) | ||
| OVERDOSE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| THERMAL BURN | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Investigations | ||||
| INTERNATIONAL NORMALISED RATIO INCREASED | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 11/1305 (0.8%) | 18/1283 (1.4%) | ||
| HYPOVOLAEMIA | 4/1305 (0.3%) | 2/1283 (0.2%) | ||
| HYPERGLYCAEMIA | 1/1305 (0.1%) | 2/1283 (0.2%) | ||
| HYPOGLYCAEMIA | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| HYPOKALAEMIA | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 2/1305 (0.2%) | 1/1283 (0.1%) | ||
| BONE PAIN | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| MUSCULOSKELETAL PAIN | 2/1305 (0.2%) | 0/1283 (0%) | ||
| MYALGIA | 0/1305 (0%) | 2/1283 (0.2%) | ||
| COMPARTMENT SYNDROME | 0/1305 (0%) | 1/1283 (0.1%) | ||
| MUSCLE SPASMS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| MYOSITIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| NECK PAIN | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| METASTASES TO MENINGES | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| CERVIX CARCINOMA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| MALIGNANT MELANOMA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Nervous system disorders | ||||
| SYNCOPE | 5/1305 (0.4%) | 3/1283 (0.2%) | ||
| CONVULSION | 1/1305 (0.1%) | 3/1283 (0.2%) | ||
| HEADACHE | 2/1305 (0.2%) | 2/1283 (0.2%) | ||
| MIGRAINE | 2/1305 (0.2%) | 1/1283 (0.1%) | ||
| CEREBRAL INFARCTION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| CEREBROVASCULAR ACCIDENT | 0/1305 (0%) | 1/1283 (0.1%) | ||
| DIZZINESS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Psychiatric disorders | ||||
| DEPRESSION | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| ANXIETY | 1/1305 (0.1%) | 0/1283 (0%) | ||
| CONFUSIONAL STATE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Renal and urinary disorders | ||||
| NEPHROLITHIASIS | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| URINARY RETENTION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Reproductive system and breast disorders | ||||
| BREAST MASS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| MENOMETRORRHAGIA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| MENORRHAGIA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| PELVIC PAIN | 1/1305 (0.1%) | 0/1283 (0%) | ||
| VAGINAL HAEMORRHAGE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| VAGINAL LACERATION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| DYSPNOEA | 5/1305 (0.4%) | 5/1283 (0.4%) | ||
| PULMONARY EMBOLISM | 3/1305 (0.2%) | 3/1283 (0.2%) | ||
| PLEURITIC PAIN | 1/1305 (0.1%) | 2/1283 (0.2%) | ||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| PNEUMOTHORAX | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| ACUTE RESPIRATORY FAILURE | 1/1305 (0.1%) | 0/1283 (0%) | ||
| ALVEOLITIS ALLERGIC | 1/1305 (0.1%) | 0/1283 (0%) | ||
| COUGH | 1/1305 (0.1%) | 0/1283 (0%) | ||
| DYSPNOEA EXERTIONAL | 1/1305 (0.1%) | 0/1283 (0%) | ||
| HYPOXIA | 1/1305 (0.1%) | 0/1283 (0%) | ||
| LUNG INFILTRATION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| PNEUMONITIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| RESPIRATORY DISTRESS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| RESPIRATORY FAILURE | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | 1/1305 (0.1%) | 1/1283 (0.1%) | ||
| RASH | 2/1305 (0.2%) | 0/1283 (0%) | ||
| SKIN DISORDER | 0/1305 (0%) | 1/1283 (0.1%) | ||
| SKIN ULCER | 0/1305 (0%) | 1/1283 (0.1%) | ||
| Social circumstances | ||||
| BREAST PROSTHESIS USER | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Surgical and medical procedures | ||||
| BREAST RECONSTRUCTION | 0/1305 (0%) | 1/1283 (0.1%) | ||
| LYMPHADENECTOMY | 0/1305 (0%) | 1/1283 (0.1%) | ||
| NEOPLASM PROPHYLAXIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| PROPHYLAXIS | 1/1305 (0.1%) | 0/1283 (0%) | ||
| SIMPLE MASTECTOMY | 1/1305 (0.1%) | 0/1283 (0%) | ||
| Vascular disorders | ||||
| DEEP VEIN THROMBOSIS | 8/1305 (0.6%) | 7/1283 (0.5%) | ||
| HYPOTENSION | 2/1305 (0.2%) | 3/1283 (0.2%) | ||
| SUBCLAVIAN VEIN THROMBOSIS | 2/1305 (0.2%) | 0/1283 (0%) | ||
| THROMBOSIS | 2/1305 (0.2%) | 0/1283 (0%) | ||
| AORTITIS | 0/1305 (0%) | 1/1283 (0.1%) | ||
| HYPERTENSION | 1/1305 (0.1%) | 0/1283 (0%) | ||
| VENOUS OCCLUSION | 1/1305 (0.1%) | 0/1283 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| AC Then T | AC Then XT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1301/1305 (99.7%) | 1283/1283 (100%) | ||
| Blood and lymphatic system disorders | ||||
| NEUTROPENIA | 966/1305 (74%) | 964/1283 (75.1%) | ||
| ANAEMIA | 729/1305 (55.9%) | 667/1283 (52%) | ||
| LEUKOPENIA | 491/1305 (37.6%) | 443/1283 (34.5%) | ||
| THROMBOCYTOPENIA | 87/1305 (6.7%) | 66/1283 (5.1%) | ||
| Ear and labyrinth disorders | ||||
| EAR PAIN | 65/1305 (5%) | 69/1283 (5.4%) | ||
| Eye disorders | ||||
| LACRIMATION INCREASED | 452/1305 (34.6%) | 396/1283 (30.9%) | ||
| VISION BLURRED | 74/1305 (5.7%) | 95/1283 (7.4%) | ||
| Gastrointestinal disorders | ||||
| NAUSEA | 1125/1305 (86.2%) | 1118/1283 (87.1%) | ||
| STOMATITIS ALL | 848/1305 (65%) | 980/1283 (76.4%) | ||
| DIARRHOEA | 581/1305 (44.5%) | 759/1283 (59.2%) | ||
| VOMITING | 618/1305 (47.4%) | 591/1283 (46.1%) | ||
| CONSTIPATION | 552/1305 (42.3%) | 596/1283 (46.5%) | ||
| DYSPEPSIA | 289/1305 (22.1%) | 389/1283 (30.3%) | ||
| ABDOMINAL PAIN | 159/1305 (12.2%) | 249/1283 (19.4%) | ||
| DRY MOUTH | 82/1305 (6.3%) | 146/1283 (11.4%) | ||
| DYSPHAGIA | 65/1305 (5%) | 133/1283 (10.4%) | ||
| GASTROOESOPHAGEAL REFLUX DISEASE | 94/1305 (7.2%) | 86/1283 (6.7%) | ||
| HAEMORRHOIDS | 91/1305 (7%) | 87/1283 (6.8%) | ||
| ABDOMINAL PAIN UPPER | 64/1305 (4.9%) | 101/1283 (7.9%) | ||
| ORAL PAIN | 65/1305 (5%) | 87/1283 (6.8%) | ||
| ABDOMINAL DISTENSION | 42/1305 (3.2%) | 69/1283 (5.4%) | ||
| FLATULENCE | 31/1305 (2.4%) | 70/1283 (5.5%) | ||
| General disorders | ||||
| FATIGUE | 1123/1305 (86.1%) | 1157/1283 (90.2%) | ||
| PYREXIA | 369/1305 (28.3%) | 339/1283 (26.4%) | ||
| OEDEMA PERIPHERAL | 324/1305 (24.8%) | 305/1283 (23.8%) | ||
| ASTHENIA | 196/1305 (15%) | 179/1283 (14%) | ||
| OEDEMA | 184/1305 (14.1%) | 139/1283 (10.8%) | ||
| CHILLS | 147/1305 (11.3%) | 165/1283 (12.9%) | ||
| PAIN | 114/1305 (8.7%) | 116/1283 (9%) | ||
| CHEST PAIN | 83/1305 (6.4%) | 89/1283 (6.9%) | ||
| Infections and infestations | ||||
| UPPER RESPIRATORY TRACT INFECTION | 165/1305 (12.6%) | 159/1283 (12.4%) | ||
| CANDIDIASIS | 112/1305 (8.6%) | 134/1283 (10.4%) | ||
| SINUSITIS | 106/1305 (8.1%) | 103/1283 (8%) | ||
| URINARY TRACT INFECTION | 106/1305 (8.1%) | 98/1283 (7.6%) | ||
| PHARYNGITIS | 70/1305 (5.4%) | 119/1283 (9.3%) | ||
| ORAL CANDIDIASIS | 84/1305 (6.4%) | 84/1283 (6.5%) | ||
| RHINITIS | 66/1305 (5.1%) | 78/1283 (6.1%) | ||
| VULVOVAGINAL MYCOTIC INFECTION | 75/1305 (5.7%) | 56/1283 (4.4%) | ||
| Investigations | ||||
| NEUTROPHIL COUNT DECREASED | 132/1305 (10.1%) | 118/1283 (9.2%) | ||
| WHITE BLOOD CELL COUNT DECREASED | 117/1305 (9%) | 116/1283 (9%) | ||
| ALANINE AMINOTRANSFERASE INCREASED | 101/1305 (7.7%) | 123/1283 (9.6%) | ||
| ASPARTATE AMINOTRANSFERASE INCREASED | 83/1305 (6.4%) | 104/1283 (8.1%) | ||
| HAEMOGLOBIN DECREASED | 93/1305 (7.1%) | 85/1283 (6.6%) | ||
| WEIGHT DECREASED | 67/1305 (5.1%) | 50/1283 (3.9%) | ||
| Metabolism and nutrition disorders | ||||
| DECREASED APPETITE | 440/1305 (33.7%) | 455/1283 (35.5%) | ||
| HYPERGLYCAEMIA | 306/1305 (23.4%) | 278/1283 (21.7%) | ||
| DEHYDRATION | 131/1305 (10%) | 110/1283 (8.6%) | ||
| HYPOKALAEMIA | 68/1305 (5.2%) | 75/1283 (5.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| MYALGIA | 671/1305 (51.4%) | 566/1283 (44.1%) | ||
| ARTHRALGIA | 616/1305 (47.2%) | 503/1283 (39.2%) | ||
| BONE PAIN | 218/1305 (16.7%) | 177/1283 (13.8%) | ||
| PAIN IN EXTREMITY | 186/1305 (14.3%) | 187/1283 (14.6%) | ||
| BACK PAIN | 166/1305 (12.7%) | 152/1283 (11.8%) | ||
| MUSCULOSKELETAL PAIN | 69/1305 (5.3%) | 61/1283 (4.8%) | ||
| Nervous system disorders | ||||
| DYSGEUSIA | 450/1305 (34.5%) | 534/1283 (41.6%) | ||
| HEADACHE | 413/1305 (31.6%) | 464/1283 (36.2%) | ||
| NEUROPATHY PERIPHERAL | 327/1305 (25.1%) | 259/1283 (20.2%) | ||
| DIZZINESS | 205/1305 (15.7%) | 258/1283 (20.1%) | ||
| PERIPHERAL SENSORY NEUROPATHY | 227/1305 (17.4%) | 187/1283 (14.6%) | ||
| PARAESTHESIA | 109/1305 (8.4%) | 99/1283 (7.7%) | ||
| HYPOAESTHESIA | 68/1305 (5.2%) | 50/1283 (3.9%) | ||
| Psychiatric disorders | ||||
| INSOMNIA | 381/1305 (29.2%) | 397/1283 (30.9%) | ||
| DEPRESSION | 218/1305 (16.7%) | 182/1283 (14.2%) | ||
| ANXIETY | 214/1305 (16.4%) | 183/1283 (14.3%) | ||
| Renal and urinary disorders | ||||
| DYSURIA | 77/1305 (5.9%) | 48/1283 (3.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| COUGH | 295/1305 (22.6%) | 302/1283 (23.5%) | ||
| OROPHARYNGEAL PAIN | 222/1305 (17%) | 258/1283 (20.1%) | ||
| DYSPNOEA | 246/1305 (18.9%) | 214/1283 (16.7%) | ||
| EPISTAXIS | 89/1305 (6.8%) | 146/1283 (11.4%) | ||
| RHINITIS ALLERGIC | 113/1305 (8.7%) | 97/1283 (7.6%) | ||
| RHINORRHOEA | 61/1305 (4.7%) | 78/1283 (6.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| ALOPECIA | 1113/1305 (85.3%) | 1069/1283 (83.3%) | ||
| PALMAR-PLANTAR | 232/1305 (17.8%) | 779/1283 (60.7%) | ||
| NAIL DISORDER | 433/1305 (33.2%) | 491/1283 (38.3%) | ||
| RASH | 357/1305 (27.4%) | 316/1283 (24.6%) | ||
| DRY SKIN | 125/1305 (9.6%) | 177/1283 (13.8%) | ||
| ERYTHEMA | 93/1305 (7.1%) | 137/1283 (10.7%) | ||
| PRURITUS | 88/1305 (6.7%) | 98/1283 (7.6%) | ||
| Vascular disorders | ||||
| HOT FLUSH | 373/1305 (28.6%) | 347/1283 (27%) | ||
| FLUSHING | 114/1305 (8.7%) | 158/1283 (12.3%) | ||
| LYMPHOEDEMA | 124/1305 (9.5%) | 71/1283 (5.5%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffman-LaRoche |
| Phone | 800-821-8590 |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00089479
Other Study ID Numbers:
- NO17629
First Posted:
Aug 6, 2004
Last Update Posted:
Dec 21, 2012
Last Verified:
Dec 1, 2012