Trial Outcomes & Findings for Ribociclib and Letrozole Treatment in Ovarian Cancer (NCT NCT03673124)

NCT ID: NCT03673124

Last Updated: 2025-12-23

Results Overview

ORR was defined as the percentage of participants in the analysis population who achieved a complete response or partial response, as assessed by RECIST 1.1.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months.
• Results posted on: 2025-12-23

Participant Flow

A total of 74 participants were screened for eligibility in the study. Out of these, 51 participants were determined to be eligible for enrollment. The recruitment period spanned from June 2018 to February of 2023.The first patient was enrolled on May 20, 2019.

Participant milestones

Measure	Ribociclib and Letrozole Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days. Treatment continues until disease progression or unacceptable toxicity.
Overall Study STARTED	51
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Ribociclib and Letrozole Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days. Treatment continues until disease progression or unacceptable toxicity.
Overall Study Eligible with no protocol therapy	2

Baseline Characteristics

Ribociclib and Letrozole Treatment in Ovarian Cancer

Baseline characteristics by cohort

Measure	Ribociclib and Letrozole n=49 Participants Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days. Treatment continues until disease progression or unacceptable toxicity.
Age, Customized Age (Years) · 20-29	4 Participants n=68 Participants
Age, Customized Age (Years) · 30-39	6 Participants n=68 Participants
Age, Customized Age (Years) · 40-49	7 Participants n=68 Participants
Age, Customized Age (Years) · 50-59	8 Participants n=68 Participants
Age, Customized Age (Years) · 60-69	17 Participants n=68 Participants
Age, Customized Age (Years) · 70-79	6 Participants n=68 Participants
Age, Customized Age (Years) · 80-89	1 Participants n=68 Participants
Sex: Female, Male Female	49 Participants n=68 Participants
Sex: Female, Male Male	0 Participants n=68 Participants
Race/Ethnicity, Customized Race · Black	3 Participants n=68 Participants
Race/Ethnicity, Customized Race · White	44 Participants n=68 Participants
Race/Ethnicity, Customized Race · Unknown	1 Participants n=68 Participants
Race/Ethnicity, Customized Race · Declined to Report	1 Participants n=68 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	9 Participants n=68 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	38 Participants n=68 Participants
Race/Ethnicity, Customized Ethnicity · Declined to Report	1 Participants n=68 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	1 Participants n=68 Participants
Region of Enrollment United States	49 Participants n=68 Participants
Performance Status (ECOG) ECOG 0	27 Participants n=68 Participants
Performance Status (ECOG) ECOG 1	21 Participants n=68 Participants
Performance Status (ECOG) Not Reported	1 Participants n=68 Participants
Site of Disease Ovary	44 Participants n=68 Participants
Site of Disease Peritoneum	5 Participants n=68 Participants
FIGO Stage at Diagnosis (ohr) I	2 Participants n=68 Participants
FIGO Stage at Diagnosis (ohr) II	1 Participants n=68 Participants
FIGO Stage at Diagnosis (ohr) III	36 Participants n=68 Participants
FIGO Stage at Diagnosis (ohr) IV	9 Participants n=68 Participants
FIGO Stage at Diagnosis (ohr) Not Reported	1 Participants n=68 Participants
Prior Surgery No	3 Participants n=68 Participants
Prior Surgery Yes	46 Participants n=68 Participants
Prior Radiation Therapy (ohr) No	48 Participants n=68 Participants
Prior Radiation Therapy (ohr) Yes	1 Participants n=68 Participants
Any Prior Immunologic/Chemo/Hormonal/Biologic/Antiangiogenic/Other therapy No	3 Participants n=68 Participants
Any Prior Immunologic/Chemo/Hormonal/Biologic/Antiangiogenic/Other therapy Yes	46 Participants n=68 Participants
Lines of Prior Therapy (ohr) 0	3 Participants n=68 Participants
Lines of Prior Therapy (ohr) 1	20 Participants n=68 Participants
Lines of Prior Therapy (ohr) 2	7 Participants n=68 Participants
Lines of Prior Therapy (ohr) 3	6 Participants n=68 Participants
Lines of Prior Therapy (ohr) 4	7 Participants n=68 Participants
Lines of Prior Therapy (ohr) 5	1 Participants n=68 Participants
Lines of Prior Therapy (ohr) 6 or more	5 Participants n=68 Participants

PRIMARY outcome

Timeframe: Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months.

Population: Eligible participants who received any amount of protocol therapy

ORR was defined as the percentage of participants in the analysis population who achieved a complete response or partial response, as assessed by RECIST 1.1.

Outcome measures

Measure	Ribociclib and Letrozole n=49 Participants Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days.
Objective Response Rate (ORR)	30.6 Percentage of participants Interval 19.9 to 43.2

SECONDARY outcome

Timeframe: Every 3 cycles during treatment period and at least 4 weeks after the first observation of a complete or partial response assessed up to approximately 55.9 months. The average study treatment time was 16.4 months.

Population: Eligible participants who received any amount of protocol therapy.

CBR was defined as the percentage of participants in the analysis population who achieved a complete response, partial response, or stable disease, as assessed by RECIST 1.1.

Outcome measures

Measure	Ribociclib and Letrozole n=49 Participants Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days.
Clinical Benefit Rate (CBR)	83.7 Percentage of participants Interval 72.5 to 91.6

SECONDARY outcome

Timeframe: During treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months.

Population: Eligible participants who received any amount of protocol therapy.

Number of participants who experienced at least one adverse event of grade 3 or higher. Adverse events were graded and categorized using CTCAE v5.0.

Outcome measures

Measure	Ribociclib and Letrozole n=49 Participants Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days.
Incidence of Adverse Events (Grade 3 or Higher) Investigations	25 participants
Incidence of Adverse Events (Grade 3 or Higher) Metabolism and nutrition disorders	6 participants
Incidence of Adverse Events (Grade 3 or Higher) Musculoskeletal and connective tissue disorders	3 participants
Incidence of Adverse Events (Grade 3 or Higher) Nervous system disorders	2 participants
Incidence of Adverse Events (Grade 3 or Higher) Psychiatric disorders	1 participants
Incidence of Adverse Events (Grade 3 or Higher) Renal and urinary disorders	3 participants
Incidence of Adverse Events (Grade 3 or Higher) Respiratory, thoracic and mediastinal disorders	3 participants
Incidence of Adverse Events (Grade 3 or Higher) Skin and subcutaneous tissue disorders	1 participants
Incidence of Adverse Events (Grade 3 or Higher) Vascular disorders	5 participants
Incidence of Adverse Events (Grade 3 or Higher) Blood and lymphatic system disorders	2 participants
Incidence of Adverse Events (Grade 3 or Higher) Cardiac disorders	1 participants
Incidence of Adverse Events (Grade 3 or Higher) Eye disorders	1 participants
Incidence of Adverse Events (Grade 3 or Higher) Gastrointestinal disorders	15 participants
Incidence of Adverse Events (Grade 3 or Higher) General disorders and administration site conditions	2 participants
Incidence of Adverse Events (Grade 3 or Higher) Infections and infestations	6 participants
Incidence of Adverse Events (Grade 3 or Higher) Injury, poisoning and procedural complications	2 participants

SECONDARY outcome

Timeframe: From date of protocol entry to date of first documented progression or death assessed up to approximately 55 months

Population: Eligible participants who received any amount of protocol therapy

PFS was defined as the time from study entry to the first documented disease progression, or death from any cause, whichever occurs first. Disease progression was assessed by RECIST 1.1.

Outcome measures

Measure	Ribociclib and Letrozole n=49 Participants Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days.
Progression-free Survival (PFS)	14.5 Months Interval 10.1 to 28.8

SECONDARY outcome

Timeframe: From date of protocol entry to date of death assessed up to approximately 62 months.

Population: Eligible participants who received any amount of protocol therapy.

OS was defined as the time from study entry to death from any cause.

Outcome measures

Measure	Ribociclib and Letrozole n=49 Participants Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle in combination with Letrozole 2.5 mg administered orally daily for 28 days.
Overall Survival (OS)	44.5 Months Interval 31.8 to The number of events was not sufficient for the estimation of this parameter (i.e. upper limit of the CI)

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of primary and secondary outcome analysis up to 5 years.

Determine the expression of estrogen receptor (ER) and correlation with response and clinical benefit.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of primary and secondary outcome analysis up to 5 years

Determine genomic signatures associated with response and clinical benefit of the combination of letrozole + Ribociclib

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of primary and secondary outcome analysis up to 5 years

Determine the expression of progesterone receptor (PR) and correlation with response and clinical benefit.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of primary and secondary outcome analysis up to 5 years

Determine the expression of proliferative index (ki-67) and correlation with response and clinical benefit.

Outcome measures

Outcome data not reported

Adverse Events

Ribociclib and Letrozole

Serious events: 29 serious events

Other events: 49 other events

Deaths: 22 deaths

Serious adverse events

Measure	Ribociclib and Letrozole n=49 participants at risk Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle plus Letrozole 2.5 mg administered orally daily for 28 days.
Blood and lymphatic system disorders Anemia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Sinus Tachycardia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Pericarditis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Cardiac Arrest	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Eye Disorders - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Colitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Vomiting	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Pancreatitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Small Intestinal Obstruction	12.2% 6/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Gastrointestinal Disorders - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Ascites	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Abdominal Pain	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Ileus	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Esophagitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Fever	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Urinary Tract Infection	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Small Intestine Infection	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Shingles	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Sepsis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Infections And Infestations - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Kidney Infection	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Injury, poisoning and procedural complications Injury, Poisoning And Procedural Complications - O	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyperglycemia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Dehydration	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Anorexia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Alcohol Intolerance	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Pain In Extremity	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder - O	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Flank Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Nervous System Disorders - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Headache	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Dizziness	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Psychiatric disorders Suicide Attempt	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Renal Calculi	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Vascular disorders Hypertension	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.

Other adverse events

Measure	Ribociclib and Letrozole n=49 participants at risk Ribociclib 600 mg administered orally daily for 21 days followed by 7 days off in 28-day treatment cycle plus Letrozole 2.5 mg administered orally daily for 28 days.
Gastrointestinal disorders Constipation	34.7% 17/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Colitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Vomiting	36.7% 18/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Stomach Pain	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Toothache	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Rectal Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Bloating	22.4% 11/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Rectal Hemorrhage	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Anal Fissure	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Folliculitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Abdominal Distension	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Eye Infection	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Lymphocyte Count Increased	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Lymphocyte Count Decreased	22.4% 11/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Periodontal Disease	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Pancreatitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Small Intestinal Obstruction	12.2% 6/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Nausea	57.1% 28/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Mucositis Oral	22.4% 11/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Gastroesophageal Reflux Disease	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Hemorrhoids	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Investigations - Other	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Inr Increased	16.3% 8/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Gastrointestinal Disorders - Other	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Ascites	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Flatulence	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Abdominal Pain	42.9% 21/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Gastritis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Ileus	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Esophagitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Belching	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Dyspepsia	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Pain	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Malaise	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Injection Site Reaction	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Flu Like Symptoms	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Fever	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Creatinine Increased	44.9% 22/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Cpk Increased	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders General Disorders And Administration Site Conditio	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Fatigue	61.2% 30/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Gait Disturbance	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Non-Cardiac Chest Pain	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Edema Limbs	12.2% 6/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
General disorders Chills	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Hepatobiliary disorders Hepatobiliary Disorders - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Immune system disorders Allergic Reaction	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Urinary Tract Infection	20.4% 10/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Thrush	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Cholesterol High	12.2% 6/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Vaginal Infection	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Lipase Increased	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Small Intestine Infection	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Skin Infection	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Sinusitis	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Shingles	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Sepsis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Otitis Media	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Blood Bilirubin Increased	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Infections And Infestations - Other	16.3% 8/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Chest Pain - Cardiac	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Cardiac Arrest	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Ear and labyrinth disorders Ear And Labyrinth Disorders - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Ear and labyrinth disorders Vertigo	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Ear and labyrinth disorders Ear Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Eye Disorders - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Floaters	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Dry Eye	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Eyelid Function Disorder	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Eye Pain	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Blurred Vision	18.4% 9/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Papilledema	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Watering Eyes	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Eye disorders Photophobia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Diarrhea	44.9% 22/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Gastrointestinal disorders Dry Mouth	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Blood and lymphatic system disorders Anemia	51.0% 25/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Blood and lymphatic system disorders Blood And Lymphatic System Disorders - Other	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Palpitations	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Sinus Bradycardia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Atrial Fibrillation	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Sinus Tachycardia	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Cardiac Disorders - Other	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Cardiac disorders Pericarditis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Herpes Simplex Reactivation	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Kidney Infection	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Upper Respiratory Infection	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Infections and infestations Bacteremia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Injury, poisoning and procedural complications Prolapse Of Intestinal Stoma	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Injury, poisoning and procedural complications Intestinal Stoma Site Bleeding	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Injury, poisoning and procedural complications Injury, Poisoning And Procedural Complications - O	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Injury, poisoning and procedural complications Fracture	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Injury, poisoning and procedural complications Fall	12.2% 6/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Weight Loss	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Weight Gain	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Platelet Count Decreased	16.3% 8/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Neutrophil Count Decreased	69.4% 34/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations White Blood Cell Decreased	55.1% 27/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Aspartate Aminotransferase Increased	20.4% 10/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Alkaline Phosphatase Increased	24.5% 12/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Alanine Aminotransferase Increased	22.4% 11/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Investigations Activated Partial Thromboplastin Time Prolonged	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Metabolism And Nutrition Disorders - Other	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypophosphatemia	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyponatremia	18.4% 9/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypokalemia	20.4% 10/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypoglycemia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypocalcemia	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypoalbuminemia	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyperuricemia	20.4% 10/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypertriglyceridemia	18.4% 9/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyperphosphatemia	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypomagnesemia	20.4% 10/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypermagnesemia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyperkalemia	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyperglycemia	26.5% 13/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypercalcemia	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Dehydration	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Anorexia	32.7% 16/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Alcohol Intolerance	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Chest Wall Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Bone Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Back Pain	24.5% 12/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Arthralgia	18.4% 9/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Pain In Extremity	18.4% 9/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Neck Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Osteoporosis	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder - O	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Muscle Cramp	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Flank Pain	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Tremor	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Syncope	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Stroke	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Peripheral Sensory Neuropathy	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Neuralgia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Nervous System Disorders - Other	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Lethargy	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Headache	34.7% 17/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Paresthesia	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Presyncope	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Extrapyramidal Disorder	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Dysgeusia	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Nervous system disorders Dizziness	20.4% 10/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Psychiatric disorders Suicide Attempt	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Psychiatric disorders Psychiatric Disorders - Other	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Psychiatric disorders Insomnia	18.4% 9/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Psychiatric disorders Depression	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Psychiatric disorders Anxiety	12.2% 6/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Urinary Tract Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Urinary Frequency	16.3% 8/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Renal Calculi	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Renal And Urinary Disorders - Other	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Proteinuria	24.5% 12/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Urinary Incontinence	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Urinary Urgency	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Hematuria	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Glucosuria	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Dysuria	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Cystitis Noninfective	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Chronic Kidney Disease	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Bladder Spasm	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Renal and urinary disorders Acute Kidney Injury	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Vaginal Hemorrhage	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Vaginal Dryness	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Vaginal Discharge	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Uterine Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Reproductive System And Breast Disorders - Other	6.1% 3/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Pelvic Pain	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Vaginal Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Reproductive system and breast disorders Breast Pain	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Tracheal Stenosis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Sore Throat	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Sneezing	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Productive Cough	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	8.2% 4/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Hoarseness	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.4% 10/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 14/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Urticaria	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	14.3% 7/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	22.4% 11/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Pruritus	10.2% 5/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Nail Changes	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Skin Hypopigmentation	4.1% 2/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Eczema	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Dry Skin	16.3% 8/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Alopecia	24.5% 12/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Vascular disorders Thromboembolic Event	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Vascular disorders Hypotension	2.0% 1/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Vascular disorders Hypertension	22.4% 11/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.
Vascular disorders Hot Flashes	32.7% 16/49 • The time frame for adverse events was during treatment period and up to 30 days after discontinuation of protocol therapy. The median duration of study treatment was 10 months with a range from 3 days to 55.9 months. The time frame for all-cause mortality was from date of protocol entry to date of death, assessed up to approximately 62 months. Eligible participants who received any amount of protocol therapy.

Additional Information

Brian Slomovitz, MD

The GOG Foundation, Inc.

Phone: 1-215-854-0770

Email: bslomovitz@gog.org

Results disclosure agreements

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

Restriction type: GT60