Trial Outcomes & Findings for Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients (NCT NCT00270894)
NCT ID: NCT00270894
Last Updated: 2012-03-20
Results Overview
Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with \> 85% of the protocol-specified dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
Results posted on
2012-03-20
Participant Flow
5 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in November 2005 and was completed in June 2008.
Informed consent was obtained from all subjects, and all subjects underwent screening procedures to verify eligibility.
Participant milestones
| Measure |
Neoadjuvant Therapy
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Neoadjuvant Therapy
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Neoadjuvant Therapy
n=30 Participants
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age Continuous
|
50.1 years
STANDARD_DEVIATION 11.17 • n=93 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with \> 85% of the protocol-specified dose.
Outcome measures
| Measure |
Neoadjuvant Therapy
n=30 Participants
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
|
60 percentage of participants
|
PRIMARY outcome
Timeframe: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.
Outcome measures
| Measure |
Neoadjuvant Therapy
n=426 Events
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
CTCAE grade 3 hematologic events
|
2 Events
|
|
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
CTCAE grade 3 non-hematologic events
|
11 Events
|
|
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
CTCAE grade 4 hematologic events
|
0 Events
|
|
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
CTCAE grade 4 non-hematologic events
|
0 Events
|
SECONDARY outcome
Timeframe: At completion of neoadjuvant treatment period, up to 24 weeks.Population: 28 patients went to surgery, so 28 patients were included in the surgery sample. Note that 4 patients in the pathologic complete response (pCR) group had residual ductal carcinoma in situ (DCIS).
Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as \>= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as \< 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and \< 25% increase in sum of diameters.
Outcome measures
| Measure |
Neoadjuvant Therapy
n=28 Participants
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Pathologic Response
Pathologic complete response (pCR)
|
16 Participants
|
|
Pathologic Response
Pathologic partial response (pPR)
|
9 Participants
|
|
Pathologic Response
Stable disease (SD)
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.Population: Clinical response assessment was available for 27 patients at the time of surgery.
Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as \>= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as \< 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and \< 25% increase in sum of diameters.
Outcome measures
| Measure |
Neoadjuvant Therapy
n=27 Participants
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Clinical Response Prior to Surgery
Clinical complete response
|
20 Participants
|
|
Clinical Response Prior to Surgery
Clinical partial response
|
5 Participants
|
|
Clinical Response Prior to Surgery
Clinical stable disease
|
2 Participants
|
SECONDARY outcome
Timeframe: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36Population: Note that the number of participants analyzed changes with the study interval. At Screening n=30, after Epirubicin/Cyclophosphamide n=30, Pre-surgery n=28, Follow-up Month 6 n=28, Follow-up Month 12 n=20, Follow-up Month 24 n=9, and Follow-up Month 36 n=1.
LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up.
Outcome measures
| Measure |
Neoadjuvant Therapy
n=30 Participants
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
Screening
|
63.55 LVEF percent
Standard Deviation 7.85
|
|
Left Ventricular Ejection Fraction (LVEF)
After Epirubicin/Cyclophosphamide
|
61.94 LVEF percent
Standard Deviation 6.76
|
|
Left Ventricular Ejection Fraction (LVEF)
Pre-Surgery
|
56.88 LVEF percent
Standard Deviation 10.33
|
|
Left Ventricular Ejection Fraction (LVEF)
Follow-up Month 6
|
57.68 LVEF percent
Standard Deviation 8.21
|
|
Left Ventricular Ejection Fraction (LVEF)
Follow-up Month 12
|
58.15 LVEF percent
Standard Deviation 8.47
|
|
Left Ventricular Ejection Fraction (LVEF)
Follow-up Month 24
|
59.38 LVEF percent
Standard Deviation 3.20
|
|
Left Ventricular Ejection Fraction (LVEF)
Follow-up Month 36
|
55.00 LVEF percent
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Outcome measures
| Measure |
Neoadjuvant Therapy
n=29 Participants
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Progression-free Survival (PFS)
|
NA Months
Data from 29 patients were included in this analysis, only 3 of whom experienced disease progression. As a result, a median value of PFS could not be estimated. The earliest censored observation occurs at about 15 months.
|
SECONDARY outcome
Timeframe: Measured from day 1 of treatment until time of death, assessed up to 48 months.Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.
Outcome measures
| Measure |
Neoadjuvant Therapy
n=29 Participants
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Overall Survival (OS)
|
NA Months
Data from 29 patients were included in this analysis, only 1 of whom died during the study, an event that occurred about 20 months after start of treatment. As a result, median OS could not be estimated.
|
Adverse Events
Neoadjuvant Therapy
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Therapy
n=30 participants at risk
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Cardiac disorders
Congestive heart failure
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Injury, poisoning and procedural complications
Medical Error
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
Other adverse events
| Measure |
Neoadjuvant Therapy
n=30 participants at risk
Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
15/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Cardiac disorders
Congestive heart failure
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Cardiac disorders
Dyspnea
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Ear and labyrinth disorders
Ear ache
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Dry eyes
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Edema
|
23.3%
7/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Eye/ear twitching
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Hyperlacrimation
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Myelosis
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Visual changes
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Eye disorders
Watery eyes
|
36.7%
11/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Abdominal pain.cramps
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Acid reflux
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Difficulty swallowing
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Hemorrhage GI Anus
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Gum soreness
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Mouth sores
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Mouth tenderness
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Mucositis
|
26.7%
8/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Nausea
|
73.3%
22/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Pain - tooth
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
6/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Aches
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Chills
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Constipation
|
20.0%
6/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Cramping bilateral/lower sides
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Day sweats
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Decreased libido
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Diarrhea
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Dizziness
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fatigue
|
80.0%
24/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Fever
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Heartburn
|
16.7%
5/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Hot flashes
|
20.0%
6/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Malaise
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Nose bleed
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
General disorders
Pain
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Immune system disorders
Flushing
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Herpes simplex
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Hordeolum
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Infection
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Oral candidiasis
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Oral thrush
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Paranasal sinus reaction
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Pulmonary
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Sinus infection
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Tooth abscess
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
ALT
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Investigations
Neutrophils
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Change in appetite
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Metabolism and nutrition disorders
Weight loss
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Low extremity pain
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain - musculoskeletal
|
50.0%
15/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Shoulder/neck soreness
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Musculoskeletal and connective tissue disorders
Neck cyst
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Memory loss
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Neuropathy
|
20.0%
6/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Pain - headache
|
26.7%
8/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Peripheral paresthesia
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Taste alteration
|
30.0%
9/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Trouble concentrating
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Nervous system disorders
Burning hands and feet
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Daytime insomnia
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Daytime sleepiness
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Depression
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Psychiatric disorders
Nightmares
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Renal and urinary disorders
Polyuria
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Irregular menses
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Menstrual cramps
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Metromenorrhagia
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Pain - breast
|
16.7%
5/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Reproductive system and breast disorders
Vaginal itching
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Allergy rhinitis
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral crackles
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
6/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
13.3%
4/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus problems
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
5/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
15/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.3%
7/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Fever blister
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Fever blisters
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Itching
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
40.0%
12/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
3/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Secondary infection (nails)
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Skin and subcutaneous tissue disorders
Skin pigmentation
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Surgical and medical procedures
Sinus drainage
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hemorrhage pulmonary
|
3.3%
1/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment, up to 25 weeks.
Systematic Assessment - subjects were assessed for adverse events every other week by either the research coordinator, treating physician, or other appropriate sub-investigator.
|
Additional Information
Vice President of Scientific Affairs
Accelerated Community Oncology Research Network, Inc.
Phone: 901-435-5570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall submit to Aventis for review of confidential information and patent protection purposes, any manuscript or abstract prepared for publication at least 30 days prior to submission to publisher. Upon written request by Aventis to Sponsor within such 30 days, Sponsor agrees to delay such publication until Aventis determines that the publication will not compromise any patent rights. However, such delay shall not exceed 90 additional days.
- Publication restrictions are in place
Restriction type: OTHER