Trial Outcomes & Findings for Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00886691)

NCT ID: NCT00886691

Last Updated: 2022-02-04

Results Overview

The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as an 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 150 participants
• Primary outcome timeframe: Duration of time from start of treatment to time of progression, approximately 4 years and 6 months.
• Results posted on: 2022-02-04

Participant Flow

150 patients were enrolled into this trial. The study opened to accrual December 2010 and closed to patient entry August 2012.

Participant milestones

Measure	Everolimus (RAD001) Plus Bevacizumab EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Overall Study STARTED	75	75
Overall Study COMPLETED	75	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Measure	Everolimus (RAD001) Plus Bevacizumab n=75 Participants EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=75 Participants ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Total n=150 Participants Total of all reporting groups
Age, Customized 20-29 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 30-39 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 40-49 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Customized 50-59 years	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Age, Customized 60-69 years	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Age, Customized 70-79 years	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Age, Customized >=80 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of time from start of treatment to time of progression, approximately 4 years and 6 months.

Population: All intent to treat patients

The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as an 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Everolimus (RAD001) Plus Bevacizumab n=75 Participants EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=75 Participants ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	OS (Overall Survival) in Non-measurable Patients Patients with non- measurable disease	OS (Overall Survival) in Measurable Patients Patients with measurable disease
Progression-free Survival	5.9 months Interval 4.11 to 7.69	4.5 months Interval 3.75 to 6.9	—	—

SECONDARY outcome

Timeframe: All Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during treatment and up to 30 days after stopping the study treatment, approximately 4 years and 6 months.

Population: All Intent to treat patients.

Number of participants with a grade of 3 or higher during the treatment period.

Outcome measures

Measure	Everolimus (RAD001) Plus Bevacizumab n=75 Participants EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=75 Participants ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	OS (Overall Survival) in Non-measurable Patients Patients with non- measurable disease	OS (Overall Survival) in Measurable Patients Patients with measurable disease
Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)	43 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: Continued until disease progression, assessed up to approximately 4 years and 6 months

Population: All Intent to treat patients

Progression-free survival and overall survival broken down by measurable disease status

Outcome measures

Measure	Everolimus (RAD001) Plus Bevacizumab n=29 Participants EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=121 Participants ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	OS (Overall Survival) in Non-measurable Patients n=29 Participants Patients with non- measurable disease	OS (Overall Survival) in Measurable Patients n=121 Participants Patients with measurable disease
Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease	3.94 Months Interval 2.63 to 5.82	5.91 Months Interval 4.27 to 7.43	11.10 Months Interval 7.59 to Insufficient follow-up time	16.92 Months Interval 12.16 to 18.43

SECONDARY outcome

Timeframe: Up to approximately 4 years and 6 months

Population: All measurable patients treated on Everolimus plus Bevicizumab and Placebo plus Bevacizumab.

Complete and Partial Tumor Response by RECIST 1.0

Outcome measures

Measure	Everolimus (RAD001) Plus Bevacizumab n=63 Participants EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=58 Participants ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	OS (Overall Survival) in Non-measurable Patients Patients with non- measurable disease	OS (Overall Survival) in Measurable Patients Patients with measurable disease
The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment.	22.2 percentage of participants responding Interval 12.7 to 34.5	12.1 percentage of participants responding Interval 5.0 to 23.3	—	—

SECONDARY outcome

Timeframe: Prior to each cycle of treatment. Then follow-up every three months for 2 years , then every 6 months for 3 years. Duration was approximately 4 years and 6 months.

Population: CA-125 evaluable patients

Response as evaluated by CA-125 levels.A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in blood.CA 125 is a tumor marker recommended for clinical use in the diagnosis and management of ovarian cancer. CA-125 responses were assessed with Rustin criteria. Initial values had to be 2x ULN (upper limit of normal) within 2 weeks of starting therapy to be considered evaluable.Patient were evaluated by using best overall response while receiving study therapy.

Outcome measures

Measure	Everolimus (RAD001) Plus Bevacizumab n=44 Participants EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=39 Participants ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	OS (Overall Survival) in Non-measurable Patients Patients with non- measurable disease	OS (Overall Survival) in Measurable Patients Patients with measurable disease
Percentage of Participants With at Least One Cancer Antigen 125 (CA-125) Response	27.3 percentage of participants Interval 15.0 to 42.8	15.4 percentage of participants Interval 5.9 to 30.5	—	—

Adverse Events

Everolimus (RAD001) Plus Bevacizumab

Serious events: 35 serious events

Other events: 73 other events

Deaths: 0 deaths

Placebo Plus Bevacizumab

Serious events: 24 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	Everolimus (RAD001) Plus Bevacizumab n=75 participants at risk EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=75 participants at risk ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Cardiac disorders Atrial Fibrillation	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Pericarditis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Colonic Obstruction	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Colonic Perforation	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Colitis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Vomiting	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Small Intestinal Obstruction	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Abdominal Pain	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Obstruction Gastric	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Ileus	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Abdominal Distension	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Nausea	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Ascites	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Non-Cardiac Chest Pain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Fatigue	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Death Nos	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Fever	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Sepsis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Lung Infection	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Urinary Tract Infection	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Catheter Related Infection	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Anorectal Infection	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Lymphocyte Count Decreased	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Aspartate Aminotransferase Increased	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypoalbuminemia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Dehydration	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Anorexia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Back Pain	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder -	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment Related Secondary Malignancy	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Intracranial Hemorrhage	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Encephalopathy	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Syncope	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Insomnia	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Depression	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Thromboembolic Event	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Hypertension	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Hematoma	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.

Other adverse events

Measure	Everolimus (RAD001) Plus Bevacizumab n=75 participants at risk EVEROLIMUS (RAD001) 10mg orally daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)	Placebo Plus Bevacizumab n=75 participants at risk ORAL PLACEBO daily plus Bevacizumab IV at 10 mg/kg Day 1 and Day 15 (one cycle = 4 weeks)
Injury, poisoning and procedural complications Bruising	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Weight Loss	20.0% 15/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Weight Gain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Serum Amylase Increased	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Platelet Count Decreased	52.0% 39/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Lymphocyte Count Decreased	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Lipase Increased	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Inr Increased	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Neutrophil Count Decreased	44.0% 33/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Cardiac Troponin I Increased	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Cpk Increased	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Blood Bilirubin Increased	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Ggt Increased	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Creatinine Increased	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Cholesterol High	38.7% 29/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Blood and lymphatic system disorders Blood And Lymphatic System Disorders - Other	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Blood and lymphatic system disorders Anemia	69.3% 52/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	34.7% 26/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Blood and lymphatic system disorders Febrile Neutropenia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Supraventricular Tachycardia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Sinus Bradycardia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Palpitations	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Heart Failure	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Atrial Flutter	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Sinus Tachycardia	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Cardiac disorders Chest Pain - Cardiac	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Ear and labyrinth disorders Ear And Labyrinth Disorders - Other	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Ear and labyrinth disorders Vertigo	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Ear and labyrinth disorders Tinnitus	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Ear and labyrinth disorders Hearing Impaired	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Ear and labyrinth disorders Ear Pain	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Ear and labyrinth disorders External Ear Pain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Endocrine disorders Hypothyroidism	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Endocrine disorders Hyperthyroidism	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Endocrine disorders Endocrine Disorders - Other	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Eye disorders Eye Disorders - Other	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Eye disorders Watering Eyes	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Eye disorders Conjunctivitis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Eye disorders Blurred Vision	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Eye disorders Dry Eye	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Eye disorders Floaters	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Dysphagia	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Dyspepsia	13.3% 10/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Duodenal Obstruction	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Dry Mouth	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Colonic Obstruction	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Colonic Perforation	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Colonic Fistula	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Colitis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Constipation	44.0% 33/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	34.7% 26/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Diarrhea	48.0% 36/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	37.3% 28/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Vomiting	41.3% 31/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	25.3% 19/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Bloating	18.7% 14/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Small Intestinal Perforation	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Stomach Pain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Small Intestinal Obstruction	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Anal Hemorrhage	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Anal Mucositis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Rectal Fistula	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Abdominal Pain	33.3% 25/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	29.3% 22/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Proctitis	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Rectal Hemorrhage	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Oral Dysesthesia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Obstruction Gastric	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Mucositis Oral	58.7% 44/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	18.7% 14/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Anal Pain	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Oral Hemorrhage	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Ileus	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Anal Ulcer	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Gingival Pain	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Oral Pain	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Abdominal Distension	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Nausea	52.0% 39/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	44.0% 33/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Gastroesophageal Reflux Disease	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Rectal Pain	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Lip Pain	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Esophagitis	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Hemorrhoids	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Ascites	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Toothache	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Dental Caries	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Flatulence	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Gastrointestinal disorders Gastritis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Pain	18.7% 14/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Malaise	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Irritability	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Flu Like Symptoms	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Edema Trunk	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Non-Cardiac Chest Pain	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Edema Limbs	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Edema Face	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Fatigue	81.3% 61/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	74.7% 56/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Fever	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Gait Disturbance	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
General disorders Chills	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Hepatobiliary disorders Portal Vein Thrombosis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Hepatobiliary disorders Cholecystitis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Immune system disorders Allergic Reaction	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Infections And Infestations - Other	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Upper Respiratory Infection	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Tooth Infection	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Skin Infection	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Sinusitis	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Sepsis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Pharyngitis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Otitis Media	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Otitis Externa	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Nail Infection	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Lung Infection	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Laryngitis	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Paronychia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Device Related Infection	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Urinary Tract Infection	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Lip Infection	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Infections and infestations Anorectal Infection	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Injury, poisoning and procedural complications Wound Dehiscence	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Injury, poisoning and procedural complications Vascular Access Complication	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Injury, poisoning and procedural complications Fall	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Injury, poisoning and procedural complications Burn	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations White Blood Cell Decreased	45.3% 34/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Aspartate Aminotransferase Increased	29.3% 22/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Alkaline Phosphatase Increased	21.3% 16/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Alanine Aminotransferase Increased	20.0% 15/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Investigations Activated Partial Thromboplastin Time Prolonged	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Metabolism And Nutrition Disorders - Other	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypophosphatemia	13.3% 10/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hyponatremia	18.7% 14/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	13.3% 10/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypomagnesemia	20.0% 15/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypokalemia	24.0% 18/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypoglycemia	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypocalcemia	22.7% 17/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypoalbuminemia	26.7% 20/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hyperuricemia	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypertriglyceridemia	32.0% 24/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	10.7% 8/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypernatremia	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hypermagnesemia	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hyperkalemia	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Hyperglycemia	36.0% 27/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Glucose Intolerance	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Dehydration	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Metabolism and nutrition disorders Anorexia	45.3% 34/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	20.0% 15/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Pain In Extremity	13.3% 10/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Neck Pain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	24.0% 18/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Flank Pain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Chest Wall Pain	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Buttock Pain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Back Pain	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	21.3% 16/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Arthritis	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Arthralgia	21.3% 16/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	26.7% 20/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder -	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Tremor	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Peripheral Sensory Neuropathy	33.3% 25/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	33.3% 25/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Paresthesia	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Memory Impairment	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Headache	41.3% 31/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	38.7% 29/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Dysphasia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Dysgeusia	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Dysarthria	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Syncope	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Dizziness	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	10.7% 8/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Nervous system disorders Cognitive Disturbance	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Psychiatric Disorders - Other	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Libido Decreased	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Insomnia	20.0% 15/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Hallucinations	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Depression	10.7% 8/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	16.0% 12/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Confusion	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Anxiety	16.0% 12/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	10.7% 8/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Psychiatric disorders Agitation	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Renal And Urinary Disorders - Other	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Urine Discoloration	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Urinary Urgency	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Urinary Retention	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Urinary Incontinence	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Urinary Tract Pain	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Urinary Frequency	10.7% 8/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Proteinuria	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	8.0% 6/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Hemoglobinuria	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Hematuria	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Cystitis Noninfective	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Chronic Kidney Disease	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Bladder Spasm	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Renal and urinary disorders Acute Kidney Injury	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Reproductive system and breast disorders Vaginal Pain	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Reproductive system and breast disorders Vaginal Hemorrhage	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Reproductive system and breast disorders Vaginal Dryness	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Reproductive system and breast disorders Pelvic Pain	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Reproductive system and breast disorders Menorrhagia	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Reproductive system and breast disorders Vaginal Discharge	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Reproductive system and breast disorders Vaginal Inflammation	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Voice Alteration	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Sore Throat	13.3% 10/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Sneezing	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Sinus Disorder	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal Hemorrhage	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	14.7% 11/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Hoarseness	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Hiccups	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.3% 19/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	13.3% 10/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	34.7% 26/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	21.3% 16/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Cough	24.0% 18/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	24.0% 18/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Wheezing	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Urticaria	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Skin Ulceration	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Rash Acneiform	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Purpura	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Pruritus	9.3% 7/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	22.7% 17/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Nail Ridging	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Nail Loss	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Nail Discoloration	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Dry Skin	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Skin and subcutaneous tissue disorders Alopecia	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	13.3% 10/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Surgical and medical procedures Surgical And Medical Procedures - Other	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Thromboembolic Event	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	5.3% 4/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Lymphedema	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	4.0% 3/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Hypertension	32.0% 24/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	41.3% 31/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Hot Flashes	6.7% 5/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	12.0% 9/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Hematoma	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	0.00% 0/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Vascular disorders Flushing	1.3% 1/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.	2.7% 2/75 • Study Treatment and up to 30 days after stopping study treatment, up to approximately 4 years and 6 months. The frequencies of any serious adverse event or other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.

Additional Information

Linda Gedeon for Michael Sill, PhD.

NRG Oncology

Phone: 716-845-1169

Email: lgedeon@gogstats.org

Results disclosure agreements

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

Restriction type: LTE60