Trial Outcomes & Findings for Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer (NCT NCT00265759)

Last Updated: 2025-04-23

Results Overview

The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

622 participants

Primary outcome timeframe

Up to 18 weeks

Results posted on

2025-04-23

Participant Flow

Z1031A enrolled postmenopausal women with stage II/III ER+ (Allred 6 to 8) breast cancer (BC) whose treatment was randomized to neoadjuvant AI therapy with anastrozole, exemestane or letrozole. For Z1031B the protocol was amended to include a tumor Ki67 determination after 2-4 weeks of AI.

Participant milestones

Participant milestones
Measure	Cohort A Arm I: Exemestane Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.	Cohort A Arm II: Letrozole Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.	Cohort A Arm III: Anastrozole Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.	Cohort B Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was \> 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Overall Study STARTED	124	128	125	245
Overall Study COMPLETED	124	127	123	236
Overall Study NOT COMPLETED	0	1	2	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Arm II: Letrozole Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.	Cohort A Arm III: Anastrozole Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.	Cohort B Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was \> 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Overall Study Withdrawal by Subject	1	2	2
Overall Study Cancel	0	0	3
Overall Study Ineligible	0	0	1
Overall Study Bilateral disease	0	0	2
Overall Study Discontinued due to intolerability	0	0	1

Baseline Characteristics

Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A Arm I: Exemestane n=124 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=127 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=123 Participants Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort B Arm I: Week 2 Ki67 <=10% n=165 Participants Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.	Cohort B Arm II: Week 2 Ki67 >10% n=49 Participants Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. Women whose two-week Ki67 level was \> 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.	Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present n=22 Participants Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.	Total n=610 Participants Total of all reporting groups
Age, Continuous	69 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants	65 years n=4 Participants	60 years n=21 Participants	66 years n=10 Participants	65 years n=115 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	127 Participants n=7 Participants	123 Participants n=5 Participants	165 Participants n=4 Participants	49 Participants n=21 Participants	22 Participants n=10 Participants	610 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	124 participants n=5 Participants	127 participants n=7 Participants	123 participants n=5 Participants	165 participants n=4 Participants	49 participants n=21 Participants	22 participants n=10 Participants	610 participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 18 weeks

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=124 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=127 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=123 Participants Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Clinical Response (Complete or Partial Response) Rate (Cohort A)	62.9 percentage of patients Interval 53.8 to 71.4	74.8 percentage of patients Interval 66.3 to 82.1	69.1 percentage of patients Interval 60.1 to 77.1

PRIMARY outcome

Timeframe: Up to 18 weeks

Population: The Overall Number of Participants Analyzed is a subset of the number of patients in Cohort B Arm II: Week 2 Ki67 \>10% who switched to neoadjuvant chemotherapy. The remaining number of patients in this arm were not included in this analysis due to decision to either continue with AI therapy or undergo surgery directly.

The primary aim is to assess the anti-tumor effect in terms of pathologic CR rates of neo-adjuvant chemotherapy in patients with T2-T4c, any N, M0 breast cancer (by clinical staging) who are endocrine therapy resistant (that is, their Ki-67 level is \>10 after 2-4 week of neo-adjuvant endocrine therapy alone). The pCR rate (percentage) for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=35 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)	5.7 percentage of patients Interval 0.7 to 19.1	—	—

SECONDARY outcome

Timeframe: Up to 30 days after drug therapy

Incidence of the most common grade 3+ toxicities reported to be probably, possibly, or definitely related to treatment as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (Cohort A) At each treatment evaluation, the type, severity, and attribution of each adverse event reported will be assessed using the NCI-CTCAE definitions. For each treatment, the percentage of patients who developed a severe (grade 3+) toxicity considered possibly, probably or definitively related to treatment will be determined.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=124 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=127 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=123 Participants Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Toxicity (Cohort A) Fatigue	2 percentage of patients	2 percentage of patients	3 percentage of patients
Toxicity (Cohort A) Hot flashes/flushes	2 percentage of patients	4 percentage of patients	2 percentage of patients
Toxicity (Cohort A) Joint pain	2 percentage of patients	3 percentage of patients	2 percentage of patients

SECONDARY outcome

Timeframe: 5 years

Population: Patients that received treatment and were eligible for analysis were included. Arms are combined across cohorts for survival analysis, as defined in the protocol.

Disease-free survival (DFS) is the time from surgery to the first of the following events: local, regional or distant recurrence, second primary disease, contralateral invasive breast cancer, or death due to any cause. The 5 year DFS rate and 95% confidence interval will be calculated.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=334 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=192 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Disease-free Survival (DFS) (Cohort A and B)	84.5 percentage of participants Interval 80.5 to 88.7	87.4 percentage of participants Interval 82.6 to 92.5	—

SECONDARY outcome

Timeframe: At time of surgery up to 18 weeks

Population: Overall Number of Participants Analyzed only includes patients considered marginal for breast conservation surgery prior to therapy.

The rate (percentage) of improved surgical outcome for patients considered marginal for breast conservation surgery prior to therapy for Cohort A is reported below for each treatment arm. Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=61 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=62 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=66 Participants Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)	85.2 percentage of improved surgical outcome Interval 73.3 to 92.6	77.4 percentage of improved surgical outcome Interval 64.7 to 86.7	86.4 percentage of improved surgical outcome Interval 75.2 to 93.2

SECONDARY outcome

Timeframe: At time of surgery up to 18 weeks

Population: Outcome Measure Data Not Collected.

The rate downstaging to Stage I of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgically findings are such that the maximum dimension of the invasive lesion contained in their surgical specimen is at most 2 cm and their lymph nodes are negative (by Hematoxylin \& Eosin Staining) divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the rate of downstaging to Stage I between these 2 treatments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At time of surgery up to 18 weeks

Population: Overall Number of Participants Analyzed include only patients who were evaluated for the number of positive nodes and not evaluated before or during AI therapy.

For those patients who undergo a sentinel lymph node dissection or an axillary lymph node dissection (at least 6 nodes examined with Hematoxylin \& Eosin Staining), the LNI rate (percentage) is defined as 100 times the proportion of eligible patients randomized to that treatment with at least one positive node. For each neo-adjuvant endocrine treatment, a 95% binomial confidence interval will be constructed for its true LNI rate.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=107 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=112 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=111 Participants Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Rate of Lymph Node Involvement (LNI) (Cohort A)	41.1 percentage of patients Interval 31.8 to 51.1	48.2 percentage of patients Interval 38.7 to 57.8	44.1 percentage of patients Interval 34.8 to 53.9

SECONDARY outcome

Timeframe: At time of surgery up to 18 weeks

Population: Overall Number of Participants Analyzed only includes patients who had surgery performed after completion of AI therapy.

The pathologic complete response is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes. The pathologic complete response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgical specimen is such that there is no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the pCR between these 2 treatments.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=115 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=120 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=117 Participants Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
The Pathologic Complete Response (pCR) Rate (Cohort A)	1.7 percentage of patients Interval 0.3 to 6.8	0.0 percentage of patients Interval 0.0 to 3.9	0.0 percentage of patients Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: Outcome Measure Data Not Collected.

The clinical response rate is defined as 100 times the number of eligible patients whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients. A 90% binomial confidence interval will be constructed for the true clinical response rate.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At time of surgery up to 18 weeks

Population: Overall Number of Participants Analyzed only includes patients considered candidates for mastectomy prior to therapy.

Rate (percentage) of Improved surgical outcome for patients designated as candidates for mastectomy prior to therapy (Cohort A). Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=52 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=57 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=50 Participants Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)	48.1 percentage of patients Interval 34.0 to 62.4	42.1 percentage of patients Interval 29.1 to 55.9	60.0 percentage of patients Interval 49.2 to 77.1

SECONDARY outcome

Timeframe: 5 years

Population: Patients that received treatment and were eligible for analysis were included. Arms are combined across cohorts for survival analysis, as defined in the protocol.

Overall survival (OS) will be measured from the date of randomization until the date of death. The distribution of overall survival times will be estimated using the Kaplan-Meier method. The 5 year OS rate and 95% confidence interval will be calculated.

Outcome measures

Outcome measures
Measure	Cohort A Arm I: Exemestane n=334 Participants Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=192 Participants Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Percentage of Participants With Overall Survival (Cohort A and B)	88.1 percentage of participants Interval 84.6 to 91.7	88.6 percentage of participants Interval 84.1 to 93.3	—

Adverse Events

Cohort A Arm I: Exemestane

Serious events: 9 serious events

Other events: 146 other events

Deaths: 0 deaths

Cohort A Arm II: Letrozole

Serious events: 14 serious events

Other events: 146 other events

Deaths: 0 deaths

Cohort A Arm III: Anastrozole

Serious events: 12 serious events

Other events: 140 other events

Deaths: 0 deaths

Cohort B

Serious events: 5 serious events

Other events: 123 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Matthew J. Ellis, MB, BChir, BSc., PhD, FRCP

Baylor College of Medicine

Phone: 713 798-1999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort A Arm I: Exemestane n=157 participants at risk Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=157 participants at risk Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=155 participants at risk Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort B n=144 participants at risk Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was \> 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Blood and lymphatic system disorders Blood disorder	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Blood and lymphatic system disorders Hemoglobin decreased	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/155 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Blood and lymphatic system disorders Hemolysis	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Arrhythmia	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.69% 1/144 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Cardiac disorder	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Myocardial ischemia	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Ear and labyrinth disorders Hearing impaired	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Ear and labyrinth disorders Tinnitus	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Cataract	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Diplopia	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Glaucoma	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Vision blurred	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Watering eyes	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Abdominal distension	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Constipation	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Dental prosthesis user	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Diarrhea	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Gastrointestinal disorder	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Nausea	2.5% 4/157 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.9% 3/157 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/155 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.69% 1/144 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Pancreatitis	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Vomiting	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/155 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
General disorders Edema limbs	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
General disorders Fatigue	2.5% 4/157 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	6.4% 10/157 • Number of events 11 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	3.2% 5/155 • Number of events 7 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.69% 1/144 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
General disorders Fever	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
General disorders General symptom	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
General disorders Pain	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.69% 1/144 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Infections and infestations Pneumonia	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Infections and infestations Skin infection	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.69% 1/144 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Infections and infestations Small intestine infection	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Infections and infestations Urinary tract infection	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Infections and infestations Wound infection	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Injury, poisoning and procedural complications Bruising	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Injury, poisoning and procedural complications Postoperative hemorrhage	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Injury, poisoning and procedural complications Small intestinal anastomotic leak	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Investigations Alkaline phosphatase increased	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Investigations Amylase increased	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.

Other adverse events
Measure	Cohort A Arm I: Exemestane n=157 participants at risk Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm II: Letrozole n=157 participants at risk Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort A Arm III: Anastrozole n=155 participants at risk Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection	Cohort B n=144 participants at risk Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was \> 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Blood and lymphatic system disorders Blood disorder	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Blood and lymphatic system disorders Hemoglobin decreased	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	3.2% 5/155 • Number of events 9 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Blood and lymphatic system disorders Lymphatic disorder	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Arrhythmia	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.69% 1/144 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Atrial fibrillation	1.3% 2/157 • Number of events 5 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Atrial tachycardia	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Cardiac disorder	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.9% 3/155 • Number of events 6 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Cardiac pain	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Left ventricular dysfunction	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Cardiac disorders Palpitations	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	3.2% 5/155 • Number of events 8 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.4% 2/144 • Number of events 6 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Ear and labyrinth disorders Ear disorder	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Ear and labyrinth disorders Ear pain	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Ear and labyrinth disorders Hearing impaired	0.64% 1/157 • Number of events 6 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.9% 3/157 • Number of events 13 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Ear and labyrinth disorders Hearing test abnormal	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Ear and labyrinth disorders Tinnitus	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 6 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Endocrine disorders Endocrine disorder	0.64% 1/157 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Endocrine disorders Hypothyroidism	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 5 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Cataract	0.64% 1/157 • Number of events 5 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 5 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Dry eye syndrome	0.64% 1/157 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Eye disorder	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.9% 3/155 • Number of events 5 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Eye pain	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Eyelid function disorder	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Flashing vision	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 5 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/155 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Glaucoma	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 6 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.65% 1/155 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Keratitis	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Photophobia	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Vision blurred	0.64% 1/157 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	2.5% 4/157 • Number of events 10 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Vitreous hemorrhage	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Eye disorders Watering eyes	0.64% 1/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Abdominal distension	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Abdominal pain	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.9% 3/155 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.4% 2/144 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Anal pain	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Colitis	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/157 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Constipation	8.9% 14/157 • Number of events 23 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	8.9% 14/157 • Number of events 24 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	7.7% 12/155 • Number of events 22 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	9.0% 13/144 • Number of events 19 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Dental prosthesis user	0.64% 1/157 • Number of events 1 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.64% 1/157 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Diarrhea	15.3% 24/157 • Number of events 40 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	7.0% 11/157 • Number of events 16 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	7.1% 11/155 • Number of events 16 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	3.5% 5/144 • Number of events 9 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Dry mouth	1.9% 3/157 • Number of events 5 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 6 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Dyspepsia	1.9% 3/157 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 2 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/155 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.69% 1/144 • Number of events 6 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
Gastrointestinal disorders Dysphagia	1.9% 3/157 • Number of events 3 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	1.3% 2/157 • Number of events 4 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/155 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.	0.00% 0/144 • Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years. This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.