Trial Outcomes & Findings for Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors (NCT NCT01225172)

Last Updated: 2020-08-11

Results Overview

Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

24 weeks after initiation of study treatment

Results posted on

2020-08-11

Participant Flow

77 participants were enrolled, 59 of whom were treated. Reasons for not entering treatment period included: 3 participants withdrew consent; 11 participants no longer met study criteria and 4 were due to other reasons.

Participant milestones

Participant milestones
Measure	BMS 100+LET Treatment with 100 mg BMS-754807 + 2.5 mg letrozole	BMS 100 100 mg BMS-754807 alone
Overall Study STARTED	52	7
Overall Study COMPLETED	46	6
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BMS 100+LET Treatment with 100 mg BMS-754807 + 2.5 mg letrozole	BMS 100 100 mg BMS-754807 alone
Overall Study Subject decision to stop	1	0
Overall Study Subject request to discontinue treatment	3	1
Overall Study Subject no longer meets study criteria	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMS 100+LET n=52 Participants Treatment with 100 mg BMS-754807 + 2.5 mg letrozole	BMS 100 n=7 Participants 100 mg BMS-754807 alone	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	4 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	3 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	60.0 Years STANDARD_DEVIATION 12.21 • n=5 Participants	64.4 Years STANDARD_DEVIATION 8.58 • n=7 Participants	60.5 Years STANDARD_DEVIATION 11.86 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	7 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	6 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	6 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks after initiation of study treatment

Population: PFS data was not collected for any participants because the study was terminated

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks after initiation of study treatment

Population: ORR data was not collected for any participants because the study was terminated

ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment. Participants were to be evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. This outcome measure was not met due to early termination of the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months

Population: All treated participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	BMS 100 + LET n=52 Participants Treatment with 100 mg BMS-754807 + 2.5 mg letrozole	BMS 100 n=7 Participants 100 mg BMS-754807 alone
Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths No. of deaths	5 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths No. of participants with Serious AEs	11 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths No. of participants with AEs (All grades)	51 Participants	7 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths No. of discontinuations due to AEs	11 Participants	2 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths No. of participants with non-serious AEs	51 Participants	7 Participants

SECONDARY outcome

Timeframe: 24 weeks after initiation of study treatment

Population: DOR data was not collected for any participants because the study was terminated early

DOR was to be performed to further characterize the response rate at Week 24. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR could not be assessed due to early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)

Population: All treated participants

Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin \> 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein. Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria

Outcome measures

Outcome measures
Measure	BMS 100 + LET n=52 Participants Treatment with 100 mg BMS-754807 + 2.5 mg letrozole	BMS 100 n=7 Participants 100 mg BMS-754807 alone
Number of On-study Laboratory Abnormalities: Grade 1-2 Albumin	13 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Alkaline Phosphatase (ALP)	12 Number of abnormalities	2 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Alanine Aminotransferase (ALT)	7 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Aspartate Aminotransferase (AST)	17 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Cholesterol, Total (TC)	28 Number of abnormalities	4 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Creatinine	11 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Absolute Neutrophil Count	16 Number of abnormalities	3 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Hemoglobin	27 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Lymphocytes (absolute)	32 Number of abnormalities	4 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Magnesium , serum	13 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Neutrophils (absolute)	15 Number of abnormalities	2 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Platelet count	14 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Glucose, fasting plasma	21 Number of abnormalities	3 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Phosphorus, inorganic	5 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Bilirubin, total	3 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Triglycerides	1 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Triglycerides, fasting	15 Number of abnormalities	2 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Uric acid	10 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 1-2 Leukocytes	17 Number of abnormalities	3 Number of abnormalities

SECONDARY outcome

Timeframe: Assessed from day 1 up to within 30 days of last dose (Approximately 42 months)

Population: All treated participants

Blood and urine samples were obtained at specified times points for laboratory evaluations. Clinical Laboratory Sage Panels included: Hematology: Hemoglobin, Hematocrit, Red blood cell, Total leukocyte count, including differential, Platelet count. Serum Chemistry : Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALK-P), Bilirubin, total (TB). Reflex testing of direct (conjugated) and indirect (unconjugated) bilirubin will be ordered if total bilirubin \> 5X ULN, Blood urea nitrogen (BUN or urea), Calcium, Chloride, Cholesterol, Creatinine, serum, Glucose, fasting plasma, Lactate dehydrogenase (LDH), Magnesium, Phosphorus, Potassium, Protein, total, Sodium, Triglycerides, Uric acid Urinalysis, Blood, Glucose, Ketones, Leukocyte esterase, pH, Protein Laboratory tests were graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0 criteria

Outcome measures

Outcome measures
Measure	BMS 100 + LET n=52 Participants Treatment with 100 mg BMS-754807 + 2.5 mg letrozole	BMS 100 n=7 Participants 100 mg BMS-754807 alone
Number of On-study Laboratory Abnormalities: Grade 3-4 Albumin	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Alkaline Phosphatase (ALP)	2 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Alanine Aminotransferase (ALT)	1 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Aspartate Aminotransferase (AST)	1 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Cholesterol, Total (TC)	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Creatinine	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Absolute Neutrophil Count	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Hemoglobin	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Lymphocytes (absolute)	4 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Magnesium , serum	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Neutrophils (absolute)	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Glucose, fasting plasma	6 Number of abnormalities	1 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Phosphorus, inorganic	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Platelet count	2 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Bilirubin, total	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Triglycerides	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Triglycerides, fasting	0 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Uric acid	3 Number of abnormalities	0 Number of abnormalities
Number of On-study Laboratory Abnormalities: Grade 3-4 Leukocytes	0 Number of abnormalities	0 Number of abnormalities

SECONDARY outcome

Timeframe: 24 weeks after initiation of study treatment

Population: TFR data was not collected for any participants because the study was terminated

The TFR was to be calculated as the total number of subjects who discontinued the treatment for any reason (including disease progression, treatment toxicity, and death) at 24 weeks divided by the total number of subjects randomized/assigned to the arm and treated. In the monotherapy arm, the TFR was to be assessed while subjects were on monotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks after initiation of study

Population: Data for this Outcome Measure was not collected for any participants because the study was terminated

Absolute copy numbers and relative expression of insulin receptor isoforms (IR-A, IR-B) in pre- and posttreatment fresh tumor tissues were to be measured. This outcome was not measured due to early termination of the study.

Outcome measures

Outcome data not reported

Adverse Events

BMS 100+LET

Serious events: 11 serious events

Other events: 51 other events

Deaths: 5 deaths

BMS 100

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	BMS 100+LET n=52 participants at risk Treatment with 100 mg BMS-754807 + 2.5 mg letrozole	BMS 100 n=7 participants at risk 100 mg BMS-754807 alone
Metabolism and nutrition disorders Dehydration	3.8% 2/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Metabolism and nutrition disorders Glucose Tolerance Impaired	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Metabolism and nutrition disorders Hyperglycaemia	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Metabolism and nutrition disorders Hyponatraemia	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Infections and infestations Cellulitis	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Infections and infestations Tooth Abscess	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Infections and infestations Urinary Tract Infection	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Gastrointestinal disorders Nausea	3.8% 2/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Cardiac disorders Cardiac Tamponade	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
General disorders Influenza Like Illness	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Injury, poisoning and procedural complications Contrast Media Reaction	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Musculoskeletal and connective tissue disorders Bone Pain	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Renal and urinary disorders Hydronephrosis	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	0.00% 0/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time
Infections and infestations Urosepsis	0.00% 0/52 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time	14.3% 1/7 • Day 1 up to within 30 days of last dose (Approximately 42 months) AEs were collected starting at study medication administration on Day 1 and stopped at 7 days after the participant discontinued study medication or 7 days after the End of Treatment visit, if the visit occured at a later time