Trial Outcomes & Findings for Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT01886872)

NCT ID: NCT01886872

Last Updated: 2025-11-10

Results Overview

The Kaplan-Meier method will be used to estimate the progression free survival distributions for each arm, with median estimates provided. Progression is defined as any one of the following: an increase in number of blood lymphocytes by \>= 50% with \>= 5000 B lymphocytes/mL in patients on Arm A or those on Arms 2 or 3 no longer receiving ibrutinib, \>= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, \>= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels \> 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 547 participants
• Primary outcome timeframe: Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.
• Results posted on: 2025-11-10

Participant Flow

Of the 644 patients screened, 52 did not meet eligibility criteria, 19 did not register per Investigator decision, 16 did not register per patient decision, and 10 did not register for other reasons; these patients are thus excluded from the study before randomization.

Participant milestones

Measure	Arm A (Rituximab, Bendamustine Hydrochloride) Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ibrutinib, Rituximab) Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	183	182	182
Overall Study Evaluable for Secondary Endpoints	183	182	182
Overall Study Evaluable for Adverse Events	176	180	181
Overall Study Crossover Cohort	30	0	0
Overall Study COMPLETED	176	178	170
Overall Study NOT COMPLETED	7	4	12

Reasons for withdrawal

Measure	Arm A (Rituximab, Bendamustine Hydrochloride) Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ibrutinib, Rituximab) Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Ineligible	7	4	12

Baseline Characteristics

Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Measure	Arm A (Rituximab, Bendamustine Hydrochloride) n=183 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=182 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ibrutinib, Rituximab) n=182 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=547 Participants Total of all reporting groups
Age, Continuous	70 years n=5 Participants	71 years n=20 Participants	71 years n=40 Participants	71 years n=28 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	59 Participants n=20 Participants	57 Participants n=40 Participants	180 Participants n=28 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	123 Participants n=20 Participants	125 Participants n=40 Participants	367 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	2 Participants n=28 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	6 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	7 Participants n=20 Participants	7 Participants n=40 Participants	23 Participants n=28 Participants
Race (NIH/OMB) White	167 Participants n=5 Participants	169 Participants n=20 Participants	173 Participants n=40 Participants	509 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=20 Participants	1 Participants n=40 Participants	7 Participants n=28 Participants
ECOG Performance Status 0	98 Participants n=5 Participants	87 Participants n=20 Participants	86 Participants n=40 Participants	271 Participants n=28 Participants
ECOG Performance Status 1	75 Participants n=5 Participants	90 Participants n=20 Participants	94 Participants n=40 Participants	259 Participants n=28 Participants
ECOG Performance Status 2	10 Participants n=5 Participants	5 Participants n=20 Participants	2 Participants n=40 Participants	17 Participants n=28 Participants

PRIMARY outcome

Timeframe: Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.

The Kaplan-Meier method will be used to estimate the progression free survival distributions for each arm, with median estimates provided. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50% with >= 5000 B lymphocytes/mL in patients on Arm A or those on Arms 2 or 3 no longer receiving ibrutinib, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first.

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=170 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=176 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=178 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression Free Survival (PFS)	NA months Median and 95% CI has not been reached.	43 months Interval 38.0 to 95% Confidence interval (CI) upper limit has not been reached.	NA months Median and 95% CI has not been reached.

SECONDARY outcome

Timeframe: Time from study entry to the time of documented disease progression or death, assessed up to 2 years

Population: Patient evaluable for the primary endpoint are included in this analysis.

The Kaplan-Meier method will be used to estimate the rate of progression free survival at 2 years in each treatment arm. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50%, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first.

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=170 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=176 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=178 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression Free Survival (PFS) Rate at 2 Years	88 percentage of patients Interval 81.0 to 92.0	74 percentage of patients Interval 66.0 to 80.0	87 percentage of patients Interval 81.0 to 92.0

SECONDARY outcome

Timeframe: From the date of registration to the date of death, assessed up to 2 years

Population: Intent-to-treat analysis population.

The Kaplan-Meier method will be used to estimate the rate of overall survival at 2 years in each treatment arm. OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=182 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=183 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=182 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS) at 2 Years	94 percentage of patients Interval 89.0 to 97.0	95 percentage of patients Interval 91.0 to 98.0	90 percentage of patients Interval 85.0 to 94.0

SECONDARY outcome

Timeframe: From the date of first response until progression or death, performed at 2.5 years after the last patient enrolled; up to 4 years.

Population: Intent-to-treat analysis population achieving objective response

The Kaplan-Meier method will be used to estimate median DOR. DOR is the time from first objective status to progression or death. CR requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. PR requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL).

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=171 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=138 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=169 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Duration of Response (DOR) (Complete Response [CR], CCR, Nodular Partial Response [nPR], Partial Response [PR], and PRL)	NA months Median and 95% CI has not been reached.	50 months Interval 40.0 to 95% Confidence interval (CI) upper limit has not been reached.	NA months Median and 95% CI has not been reached.

SECONDARY outcome

Timeframe: Performed at 2.5 years after the last patient enrolled;up to 4 years.

Population: Intent-to-treat analysis population

Complete response (CR) requires all of the following: absence of lymphadenopathy >1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. Partial response (PR) requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL).Overall response rate and corresponding exact binomial 95% CI provided.

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=182 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=183 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=182 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Percentage of Patients Achieving Any Response to Treatment (Overall Response Rate [ORR] [Complete Response [CR], CCR, Nodular Partial Response [nPR], Partial Response [PR], and PRL])	94 percentage of patients Interval 89.0 to 97.0	75 percentage of patients Interval 69.0 to 81.0	93 percentage of patients Interval 88.0 to 96.0

SECONDARY outcome

Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.

Population: Intent-to-treat analysis population

Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. Complete response rate and corresponding exact binomial 95% confidence intervals provided.

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=182 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=183 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=182 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Percentage of Patients Achieving a Biopsy-proven Complete Response (CR)	12 percentage of patients Interval 8.0 to 18.0	26 percentage of patients Interval 20.0 to 33.0	7 percentage of patients Interval 4.0 to 12.0

SECONDARY outcome

Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.

Population: Intent-to-treat analysis population

Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). Response rate and corresponding exact binomial 95% confidence intervals provided.

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=182 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=183 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=182 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Percentage of Patients Achieving Complete (CR and CCR) or Nodular Partial Response (nPR)	23 percentage of patients Interval 17.0 to 30.0	33 percentage of patients Interval 27.0 to 41.0	10 percentage of patients Interval 6.0 to 16.0

SECONDARY outcome

Timeframe: Cycle 9 Day 1 Evaluation

Population: Intent-to-treat analysis population

Estimated using the number of patients who achieve minimal residual disease divided by the total number randomized to that treatment arm. Corresponding exact binomial 95% confidence intervals for MRD rates will be calculated.

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=182 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=183 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=182 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Percentage of Patients Who Attain Minimal Residual Disease (MRD) Negative Status	4 percentage of patients Interval 2.0 to 8.0	8 percentage of patients Interval 5.0 to 13.0	1 percentage of patients Interval 0.1 to 3.0

SECONDARY outcome

Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.

Population: Patients who started treatment.

The rate of grade 3, 4, or 5 treatment-related non-hematologic adverse events (toxicities) by arm; excludes adverse events occurring post-crossover for patients in Arm A

Outcome measures

Measure	Arm C (Ibrutinib, Rituximab) n=181 Participants Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Rituximab, Bendamustine Hydrochloride) n=176 Participants Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=180 Participants Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
The Rate of Grade 3, 4, or 5 Treatment-related Non-hematologic Adverse Events (Toxicities)	39 percentage of patients	41 percentage of patients	48 percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Performed at 2.5 years after the last patient enrolled

Assessed using the Older Americans' Resources and Services Multidimensional Functional Assessment Questionnaire, Activities of Daily Living, Medical Outcomes Study physical functioning, Karnofsky performance status rated by a health care professional, Karnofsky performance status rated by the patient, timed "Up and Go", and number of falls in the last six months.

Outcome measures

Outcome data not reported

Adverse Events

Arm C (Ibrutinib, Rituximab)

Serious events: 108 serious events

Other events: 181 other events

Deaths: 22 deaths

Arm B Crossover

Serious events: 16 serious events

Other events: 26 other events

Deaths: 2 deaths

Arm A (Rituximab, Bendamustine Hydrochloride)

Serious events: 87 serious events

Other events: 176 other events

Deaths: 15 deaths

Arm B (Ibrutinib)

Serious events: 112 serious events

Other events: 180 other events

Deaths: 24 deaths

Serious adverse events

Measure	Arm C (Ibrutinib, Rituximab) n=181 participants at risk Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B Crossover n=27 participants at risk Arm A patients experiencing disease progression crossover to Arm B.	Arm A (Rituximab, Bendamustine Hydrochloride) n=176 participants at risk Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=180 participants at risk Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	3.3% 6/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.0% 9/180 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Febrile neutropenia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 13/176 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Atrial fibrillation	4.4% 8/181 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	10.6% 19/180 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Atrial flutter	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Atrioventricular block complete	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Atrioventricular block first degree	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Cardiac arrest	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Cardiac disorders - Other, specify	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Chest pain - cardiac	1.7% 3/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Heart failure	2.8% 5/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Myocardial infarction	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Palpitations	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Pericardial effusion	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Pericardial tamponade	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Pericarditis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Sick sinus syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Sinus bradycardia	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Tricuspid valve disease	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Ventricular arrhythmia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Ventricular tachycardia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Ear and labyrinth disorders Hearing impaired	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Cataract	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Eye disorders - Other, specify	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Abdominal distension	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Abdominal pain	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Ascites	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Colitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Constipation	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Diarrhea	3.3% 6/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	11.1% 3/27 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Dyspepsia	1.1% 2/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Dysphagia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Enterocolitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Esophageal hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Flatulence	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gastric hemorrhage	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Ileus	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Mucositis oral	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Nausea	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Pancreatitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Small intestinal obstruction	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Vomiting	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Chills	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Death NOS	3.9% 7/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Edema face	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Edema limbs	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Fatigue	3.9% 7/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Fever	3.9% 7/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	9.1% 16/176 • Number of events 19 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Flu like symptoms	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Gait disturbance	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders General disorders and administration site conditions - Other, specify	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Infusion related reaction	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.1% 9/176 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Multi-organ failure	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Non-cardiac chest pain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Pain	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Sudden death NOS	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Hepatobiliary disorders Cholecystitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Allergic reaction	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Anaphylaxis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Cytokine release syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Abdominal infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Appendicitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Bladder infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Bone infection	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Bronchial infection	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Encephalitis infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Gallbladder infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Infections and infestations - Other, specify	2.8% 5/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Joint infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Lung infection	6.6% 12/181 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Meningitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Pharyngitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Sepsis	4.4% 8/181 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.5% 8/176 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Skin infection	5.0% 9/181 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.3% 6/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Upper respiratory infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Urinary tract infection	2.2% 4/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Wound infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Bruising	3.3% 6/181 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Fall	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Fracture	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Aspartate aminotransferase increased	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Postoperative hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Seroma	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Alanine aminotransferase increased	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Alkaline phosphatase increased	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Blood bilirubin increased	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations CPK increased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Cardiac troponin I increased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Creatinine increased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Ejection fraction decreased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Investigations - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Lymphocyte count decreased	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.0% 7/176 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Lymphocyte count increased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Neutrophil count decreased	6.1% 11/181 • Number of events 16 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.5% 15/176 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.6% 10/180 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Platelet count decreased	3.3% 6/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Weight gain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations White blood cell decreased	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Anorexia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Dehydration	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypernatremia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypoalbuminemia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypocalcemia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypokalemia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyponatremia	2.8% 5/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Back pain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Chest wall pain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Flank pain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Myalgia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Neck pain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	15.5% 28/181 • Number of events 39 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	25.9% 7/27 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	9.1% 16/176 • Number of events 21 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	11.1% 20/180 • Number of events 33 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Ataxia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Cognitive disturbance	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Depressed level of consciousness	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Dizziness	1.1% 2/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Encephalopathy	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Headache	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Intracranial hemorrhage	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Lethargy	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Leukoencephalopathy	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Nervous system disorders - Other, specify	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Paresthesia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Peripheral motor neuropathy	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Peripheral sensory neuropathy	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Presyncope	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Seizure	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Stroke	2.2% 4/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Syncope	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Transient ischemic attacks	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Confusion	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Delirium	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Psychiatric disorders - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Acute kidney injury	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Chronic kidney disease	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Hematuria	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Renal and urinary disorders - Other, specify	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary incontinence	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary retention	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 3/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 4/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.3% 6/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 3/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.0% 9/180 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Wheezing	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Dry skin	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Pruritus	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.2% 4/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Hematoma	1.7% 3/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Hypertension	3.3% 6/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.3% 6/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Hypotension	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Thromboembolic event	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.

Other adverse events

Measure	Arm C (Ibrutinib, Rituximab) n=181 participants at risk Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B Crossover n=27 participants at risk Arm A patients experiencing disease progression crossover to Arm B.	Arm A (Rituximab, Bendamustine Hydrochloride) n=176 participants at risk Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.	Arm B (Ibrutinib) n=180 participants at risk Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Atrial flutter	2.8% 5/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Palpitations	3.9% 7/181 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.0% 9/180 • Number of events 15 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Conjunctivitis	1.7% 3/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Dry eye	2.2% 4/181 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Watering eyes	1.7% 3/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Diarrhea	54.1% 98/181 • Number of events 453 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	44.4% 12/27 • Number of events 58 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	32.4% 57/176 • Number of events 95 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	52.8% 95/180 • Number of events 410 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Vomiting	8.3% 15/181 • Number of events 19 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.0% 14/176 • Number of events 20 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Chills	6.1% 11/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	12.5% 22/176 • Number of events 27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Edema face	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Edema limbs	53.0% 96/181 • Number of events 420 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	29.6% 8/27 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	23.3% 41/176 • Number of events 76 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	49.4% 89/180 • Number of events 383 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Cardiac disorders - Other, specify	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations INR increased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Weight gain	3.9% 7/181 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Weight loss	7.7% 14/181 • Number of events 30 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 13/176 • Number of events 26 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.6% 10/180 • Number of events 25 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Headache	8.8% 16/181 • Number of events 27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.0% 7/176 • Number of events 22 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.9% 16/180 • Number of events 39 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Neuralgia	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Nystagmus	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Sinus pain	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Somnolence	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Fatigue	87.3% 158/181 • Number of events 1210 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	92.6% 25/27 • Number of events 167 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	89.8% 158/176 • Number of events 578 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	83.3% 150/180 • Number of events 1165 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Fever	2.8% 5/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	11.9% 21/176 • Number of events 24 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Flu like symptoms	2.2% 4/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Gait disturbance	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Pain	6.6% 12/181 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Stroke	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Spasticity	1.1% 2/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Insomnia	4.4% 8/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.3% 15/180 • Number of events 35 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Hot flashes	1.7% 3/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Hypertension	69.6% 126/181 • Number of events 1119 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	70.4% 19/27 • Number of events 133 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	46.0% 81/176 • Number of events 276 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	67.2% 121/180 • Number of events 1146 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Hypotension	1.7% 3/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.7% 10/176 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Phlebitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Syncope	1.7% 3/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Hemolytic uremic syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Leukocytosis	6.6% 12/181 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.3% 15/180 • Number of events 43 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Anemia	72.4% 131/181 • Number of events 756 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	74.1% 20/27 • Number of events 118 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	84.1% 148/176 • Number of events 511 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	74.4% 134/180 • Number of events 743 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	2.2% 4/181 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.0% 7/176 • Number of events 15 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Bone marrow hypocellular	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Lymph node pain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Spleen disorder	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Aortic valve disease	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Atrial fibrillation	9.9% 18/181 • Number of events 45 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	14.8% 4/27 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	10.0% 18/180 • Number of events 41 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Chest pain - cardiac	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Conduction disorder	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Heart failure	0.55% 1/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Left ventricular systolic dysfunction	0.55% 1/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Myocardial infarction	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Paroxysmal atrial tachycardia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Pericardial effusion	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Pericarditis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Sick sinus syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Sinus bradycardia	2.8% 5/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 18 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Sinus tachycardia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Cardiac disorders Supraventricular tachycardia	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Ear and labyrinth disorders Ear pain	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Ear and labyrinth disorders Hearing impaired	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Ear and labyrinth disorders Middle ear inflammation	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Ear and labyrinth disorders Tinnitus	0.55% 1/181 • Number of events 15 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Ear and labyrinth disorders Vertigo	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Endocrine disorders Hypothyroidism	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Blurred vision	1.1% 2/181 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Cataract	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Eye disorders - Other, specify	2.8% 5/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Floaters	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Glaucoma	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Photophobia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Retinopathy	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Eye disorders Scleral disorder	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Abdominal pain	2.2% 4/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	10.6% 19/180 • Number of events 36 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Ascites	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Bloating	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 15 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Colitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Constipation	15.5% 28/181 • Number of events 51 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	18.8% 33/176 • Number of events 73 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.1% 11/180 • Number of events 42 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Dry mouth	5.0% 9/181 • Number of events 33 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 37 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Dyspepsia	40.3% 73/181 • Number of events 311 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	29.6% 8/27 • Number of events 42 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	17.0% 30/176 • Number of events 71 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	30.6% 55/180 • Number of events 225 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Dysphagia	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Enterocolitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Esophageal pain	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Esophageal ulcer	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Esophagitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Fecal incontinence	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Flatulence	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gastric hemorrhage	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gastritis	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gastroesophageal reflux disease	3.9% 7/181 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 26 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.8% 5/181 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 21 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.0% 9/180 • Number of events 19 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Gingival pain	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Mucositis oral	9.4% 17/181 • Number of events 53 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.2% 11/176 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	14.4% 26/180 • Number of events 79 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Nausea	19.3% 35/181 • Number of events 50 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	35.2% 62/176 • Number of events 134 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	13.9% 25/180 • Number of events 65 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Oral hemorrhage	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Oral pain	2.2% 4/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Periodontal disease	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Rectal hemorrhage	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Rectal mucositis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Stomach pain	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Toothache	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders General disorders and administration site conditions - Other, specify	7.2% 13/181 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	11.1% 3/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.1% 11/180 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Infusion related reaction	13.3% 24/181 • Number of events 24 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	41.5% 73/176 • Number of events 97 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Injection site reaction	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Localized edema	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Malaise	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
General disorders Non-cardiac chest pain	3.3% 6/181 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Hepatobiliary disorders Cholecystitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Allergic reaction	5.5% 10/181 • Number of events 18 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.2% 11/176 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Autoimmune disorder	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Cytokine release syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Immune system disorders - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Hemoglobin increased	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Immune system disorders Serum sickness	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Bronchial infection	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Catheter related infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Duodenal infection	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Enterocolitis infectious	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Eye infection	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Hepatitis viral	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Infections and infestations - Other, specify	7.2% 13/181 • Number of events 18 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.0% 7/176 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Laryngitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Lung infection	5.0% 9/181 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.5% 8/176 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Lymph gland infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Mucosal infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Nail infection	1.1% 2/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Otitis media	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Papulopustular rash	0.55% 1/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Paronychia	1.1% 2/181 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Penile infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Pharyngitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Prostate infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Rhinitis infective	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Scrotal infection	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Sepsis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Sinusitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Skin infection	7.7% 14/181 • Number of events 19 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.0% 7/176 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 22 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Soft tissue infection	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Tooth infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Upper respiratory infection	7.7% 14/181 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.1% 9/176 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Urinary tract infection	5.0% 9/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.7% 12/180 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Infections and infestations Wound infection	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Bruising	63.0% 114/181 • Number of events 738 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	51.9% 14/27 • Number of events 68 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	13.6% 24/176 • Number of events 43 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	65.0% 117/180 • Number of events 724 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Fall	2.2% 4/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Fracture	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Hip fracture	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Postoperative hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Injury, poisoning and procedural complications Wound complication	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Alanine aminotransferase increased	3.3% 6/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.8% 14/180 • Number of events 30 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Alkaline phosphatase increased	5.0% 9/181 • Number of events 20 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 16 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.6% 10/180 • Number of events 27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Aspartate aminotransferase increased	3.9% 7/181 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.1% 9/176 • Number of events 21 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.9% 16/180 • Number of events 28 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Blood bilirubin increased	15.5% 28/181 • Number of events 119 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.1% 9/176 • Number of events 27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	11.7% 21/180 • Number of events 54 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations CD4 lymphocytes decreased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Cardiac troponin I increased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Creatinine increased	12.7% 23/181 • Number of events 82 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.0% 14/176 • Number of events 24 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	10.0% 18/180 • Number of events 74 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Ejection fraction decreased	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations GGT increased	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Investigations - Other, specify	4.4% 8/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Lymphocyte count decreased	13.3% 24/181 • Number of events 62 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	25.9% 7/27 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	27.3% 48/176 • Number of events 232 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.7% 12/180 • Number of events 30 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Lymphocyte count increased	16.6% 30/181 • Number of events 80 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	37.0% 10/27 • Number of events 22 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	9.7% 17/176 • Number of events 22 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	23.3% 42/180 • Number of events 192 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Neutrophil count decreased	37.6% 68/181 • Number of events 178 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	51.9% 14/27 • Number of events 41 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	72.7% 128/176 • Number of events 356 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	33.9% 61/180 • Number of events 143 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Platelet count decreased	72.4% 131/181 • Number of events 956 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	70.4% 19/27 • Number of events 104 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	78.4% 138/176 • Number of events 490 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	71.7% 129/180 • Number of events 995 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations Urine output decreased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Investigations White blood cell decreased	9.4% 17/181 • Number of events 37 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	30.7% 54/176 • Number of events 175 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Alkalosis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Anorexia	12.7% 23/181 • Number of events 40 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	14.2% 25/176 • Number of events 35 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	11.1% 20/180 • Number of events 49 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Dehydration	1.7% 3/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.3% 6/180 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyperglycemia	5.5% 10/181 • Number of events 38 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 13/176 • Number of events 31 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	8.9% 16/180 • Number of events 37 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyperkalemia	3.9% 7/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.7% 12/180 • Number of events 25 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypernatremia	2.2% 4/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyperuricemia	2.2% 4/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 23 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypoalbuminemia	5.5% 10/181 • Number of events 24 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.1% 9/176 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.1% 11/180 • Number of events 19 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypocalcemia	3.9% 7/181 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 13/176 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.0% 9/180 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypoglycemia	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypokalemia	4.4% 8/181 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.3% 6/180 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypomagnesemia	2.8% 5/181 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hyponatremia	6.6% 12/181 • Number of events 34 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.1% 9/176 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Hypophosphatemia	1.7% 3/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Arthralgia	14.4% 26/181 • Number of events 79 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	12.2% 22/180 • Number of events 84 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Arthritis	1.1% 2/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Back pain	5.5% 10/181 • Number of events 15 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.0% 9/180 • Number of events 16 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Bone pain	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Chest wall pain	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Flank pain	1.1% 2/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.0% 9/181 • Number of events 22 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	0.55% 1/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Muscle weakness trunk	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.7% 14/181 • Number of events 44 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 13 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.8% 14/180 • Number of events 51 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Musculoskeletal deformity	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Myalgia	13.8% 25/181 • Number of events 64 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	14.8% 4/27 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.1% 9/176 • Number of events 18 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.2% 13/180 • Number of events 49 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Neck pain	1.7% 3/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Pain in extremity	8.8% 16/181 • Number of events 24 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	12.2% 22/180 • Number of events 37 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Musculoskeletal and connective tissue disorders Soft tissue necrosis lower limb	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.8% 5/181 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Ataxia	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Cognitive disturbance	0.55% 1/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Concentration impairment	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Dizziness	39.8% 72/181 • Number of events 248 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	37.0% 10/27 • Number of events 29 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	26.7% 47/176 • Number of events 86 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	38.9% 70/180 • Number of events 236 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Dysesthesia	0.55% 1/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Dysgeusia	3.3% 6/181 • Number of events 10 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	9.1% 16/176 • Number of events 30 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.9% 7/180 • Number of events 22 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Encephalopathy	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Hydrocephalus	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Intracranial hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Lethargy	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Memory impairment	1.7% 3/181 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Movements involuntary	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Nervous system disorders - Other, specify	2.2% 4/181 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Paresthesia	1.1% 2/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Peripheral motor neuropathy	0.55% 1/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Peripheral sensory neuropathy	6.6% 12/181 • Number of events 31 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.0% 9/180 • Number of events 24 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Presyncope	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Radiculitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Seizure	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Transient ischemic attacks	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Nervous system disorders Tremor	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Agitation	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Anxiety	2.8% 5/181 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.0% 7/176 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Confusion	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Depression	1.1% 2/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Libido decreased	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Psychiatric disorders Restlessness	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Acute kidney injury	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Bladder spasm	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Chronic kidney disease	3.3% 6/181 • Number of events 21 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Hematuria	5.5% 10/181 • Number of events 18 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.6% 10/180 • Number of events 22 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Proteinuria	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.2% 4/181 • Number of events 16 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Renal calculi	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary frequency	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary incontinence	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary retention	1.1% 2/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary tract pain	1.1% 2/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Renal and urinary disorders Urinary urgency	0.55% 1/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Reproductive system and breast disorders Gynecomastia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Reproductive system and breast disorders Prostatic obstruction	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Reproductive system and breast disorders Testicular pain	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Aspiration	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Cough	59.1% 107/181 • Number of events 492 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	59.3% 16/27 • Number of events 66 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	42.0% 74/176 • Number of events 153 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	54.4% 98/180 • Number of events 342 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.7% 23/181 • Number of events 45 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	13.1% 23/176 • Number of events 39 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	12.2% 22/180 • Number of events 62 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.4% 17/181 • Number of events 47 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Hiccups	1.1% 2/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Hoarseness	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Laryngopharyngeal dysesthesia	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.2% 4/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 3/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.7% 3/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Productive cough	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.1% 2/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	2.2% 4/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.3% 4/176 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Sleep apnea	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Sore throat	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 6 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Respiratory, thoracic and mediastinal disorders Wheezing	1.1% 2/181 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Alopecia	1.1% 2/181 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.3% 6/180 • Number of events 14 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Bullous dermatitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Dry skin	5.5% 10/181 • Number of events 27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.8% 5/176 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	4.4% 8/180 • Number of events 26 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Nail discoloration	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Nail loss	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Nail ridging	3.3% 6/181 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 7 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Periorbital edema	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Pruritus	6.6% 12/181 • Number of events 15 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.4% 6/176 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	5.6% 10/180 • Number of events 16 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Purpura	3.9% 7/181 • Number of events 28 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	7.4% 2/27 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 11 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Rash acneiform	2.8% 5/181 • Number of events 8 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.57% 1/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	2.2% 4/180 • Number of events 9 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Rash maculo-papular	39.8% 72/181 • Number of events 212 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	25.9% 7/27 • Number of events 16 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	32.4% 57/176 • Number of events 112 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	41.1% 74/180 • Number of events 271 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	9.9% 18/181 • Number of events 37 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	11.1% 3/27 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	6.2% 11/176 • Number of events 17 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	12.8% 23/180 • Number of events 86 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Skin ulceration	1.1% 2/181 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Skin and subcutaneous tissue disorders Urticaria	0.55% 1/181 • Number of events 5 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.56% 1/180 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Social circumstances Social circumstances - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Flushing	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 2 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Hematoma	3.3% 6/181 • Number of events 12 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	3.7% 1/27 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Superficial thrombophlebitis	0.00% 0/181 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Thromboembolic event	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Vascular disorders - Other, specify	1.1% 2/181 • Number of events 4 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.1% 2/176 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	1.7% 3/180 • Number of events 3 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.
Vascular disorders Vasculitis	0.55% 1/181 • Number of events 1 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/27 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/176 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.	0.00% 0/180 • Performed at 2.5 years after the last patient enrolled; up to 4 years. Patients who started treatment AND submitted at least one Adverse Events Form are included below.

Additional Information

Jennifer Woyach, MD

Ohio State University

Phone: 614-685-5667

Email: jennifer.woyach@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60