Trial Outcomes & Findings for Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate (NCT NCT02600923)

Last Updated: 2022-01-20

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

131 participants

Primary outcome timeframe

3 years

Results posted on

2022-01-20

Participant Flow

A total of 131 participants were enrolled and assigned to study treatment, and 130 participants were treated in the study.

Participant milestones

Participant milestones
Measure	Palbociclib+Letrozole Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Overall Study STARTED	131
Overall Study Treated	130
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	Palbociclib+Letrozole Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Overall Study Death	10
Overall Study Adverse Event	3
Overall Study Global deterioration of health status	2
Overall Study Insufficient clinical response	6
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	5
Overall Study Objective progression or relapse	50
Overall Study Study terminated by Sponsor	53
Overall Study Not treated	1

Baseline Characteristics

Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palbociclib+Letrozole n=130 Participants Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

Outcome measures

Outcome measures
Measure	Palbociclib+Letrozole n=130 Participants Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs) Grade 1	0 Participants
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs) Grade 2	17 Participants
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs) Grade 3	82 Participants
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs) Grade 4	23 Participants
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs) Grade 5	7 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Palbociclib-related TEAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Palbociclib+Letrozole n=130 Participants Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Number of Participants With Palbociclib-related TEAEs Grade 1	2 Participants
Number of Participants With Palbociclib-related TEAEs Grade 2	25 Participants
Number of Participants With Palbociclib-related TEAEs Grade 3	81 Participants
Number of Participants With Palbociclib-related TEAEs Grade 4	20 Participants
Number of Participants With Palbociclib-related TEAEs Grade 5	0 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. Palbociclib-related SAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Palbociclib+Letrozole n=130 Participants Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Number of Participants With Serious Adverse Events (SAEs) All-causality	32 Participants
Number of Participants With Serious Adverse Events (SAEs) Palbociclib-related	6 Participants

SECONDARY outcome

Timeframe: 3 years

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

Death from any cause while on treatment and within 28 days of palbociclib discontinuation was only counted below.

Outcome measures

Outcome measures
Measure	Palbociclib+Letrozole n=130 Participants Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Number of Participants With Death	5 Participants

SECONDARY outcome

Timeframe: 3 years

Population: The analysis population included participants with efficacy data contributing to the analysis.

The tumor response was based on the response reported by investigator per local practice. No response confirmation was applied. ORR was defined as the percentage of participants with complete response or partial response relative to all as-treated population.

Outcome measures

Outcome measures
Measure	Palbociclib+Letrozole n=129 Participants Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
The Objective Response Rate (ORR)	24.8 percentage of evaluable participants Interval 17.6 to 33.2

Adverse Events

Palbociclib+Letrozole

Serious events: 32 serious events

Other events: 129 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Palbociclib+Letrozole n=130 participants at risk Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Blood and lymphatic system disorders Anaemia	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Febrile neutropenia	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Neutropenia	0.77% 1/130 • Number of events 2 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Pancytopenia	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Arteriosclerosis coronary artery	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Ascites	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Chest pain	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Disease progression	1.5% 2/130 • Number of events 2 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders General physical health deterioration	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Cellulitis	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Device related infection	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Herpes virus infection	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Pneumonia	2.3% 3/130 • Number of events 3 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Tuberculosis	1.5% 2/130 • Number of events 2 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Femur fracture	1.5% 2/130 • Number of events 2 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Fractured ischium	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Road traffic accident	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypoglycaemia	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Back pain	1.5% 2/130 • Number of events 2 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Cerebrovascular accident	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Haemorrhagic stroke	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Hypertensive hydrocephalus	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Ischaemic stroke	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Spinal cord compression	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Skin ulcer	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Deep vein thrombosis	1.5% 2/130 • Number of events 3 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Vena cava thrombosis	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Platelet count decreased	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.77% 1/130 • Number of events 1 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Other adverse events
Measure	Palbociclib+Letrozole n=130 participants at risk Participants received palbociclib orally once daily at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle, and letrozole orally at 2.5 mg QD as a continuous daily dosing schedule. Participants continued to receive treatments with palbociclib+letrozole until disease progression, symptomatic deterioration, unacceptable toxicity, death, withdrawal of consent, or time of commercial availability of palbociclib, whichever occurred first.
Blood and lymphatic system disorders Anaemia	33.8% 44/130 • Number of events 111 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Leukopenia	34.6% 45/130 • Number of events 173 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Lymphopenia	8.5% 11/130 • Number of events 19 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Neutropenia	70.0% 91/130 • Number of events 709 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Thrombocytopenia	24.6% 32/130 • Number of events 89 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal distension	10.8% 14/130 • Number of events 21 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	9.2% 12/130 • Number of events 17 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain upper	6.2% 8/130 • Number of events 8 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Constipation	16.2% 21/130 • Number of events 24 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Diarrhoea	23.1% 30/130 • Number of events 50 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Dyspepsia	6.9% 9/130 • Number of events 10 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Nausea	19.2% 25/130 • Number of events 34 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Stomatitis	6.2% 8/130 • Number of events 15 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Vomiting	13.1% 17/130 • Number of events 40 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Asthenia	16.9% 22/130 • Number of events 33 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Fatigue	15.4% 20/130 • Number of events 26 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Mucosal inflammation	8.5% 11/130 • Number of events 26 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Oedema peripheral	6.9% 9/130 • Number of events 12 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pyrexia	6.2% 8/130 • Number of events 9 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Influenza	7.7% 10/130 • Number of events 11 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Nasopharyngitis	5.4% 7/130 • Number of events 14 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Upper respiratory tract infection	11.5% 15/130 • Number of events 21 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	5.4% 7/130 • Number of events 8 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Lymphocyte count decreased	12.3% 16/130 • Number of events 62 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Neutrophil count decreased	27.7% 36/130 • Number of events 259 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Platelet count decreased	14.6% 19/130 • Number of events 50 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations White blood cell count decreased	17.7% 23/130 • Number of events 129 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Decreased appetite	7.7% 10/130 • Number of events 10 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 26/130 • Number of events 31 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Back pain	16.2% 21/130 • Number of events 33 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 8/130 • Number of events 10 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	11.5% 15/130 • Number of events 23 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Dizziness	9.2% 12/130 • Number of events 14 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Headache	19.2% 25/130 • Number of events 37 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Insomnia	6.9% 9/130 • Number of events 9 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Cough	16.2% 21/130 • Number of events 25 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 8/130 • Number of events 10 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Alopecia	13.8% 18/130 • Number of events 22 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Dry skin	7.7% 10/130 • Number of events 10 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Pruritus	5.4% 7/130 • Number of events 7 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Rash	7.7% 10/130 • Number of events 13 • 3 years The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER