Trial Outcomes & Findings for Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer (NCT NCT02491983)
NCT ID: NCT02491983
Last Updated: 2024-12-09
Results Overview
Percentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
486 participants
Primary outcome timeframe
One year
Results posted on
2024-12-09
Participant Flow
Postmenopausal women and premenopausal women receiving LHRH analogues, aged ≥ 18 years with ER+ and HER2- with laBC or mBC that had not received any therapy for the metastatic disease.
Screening details: * Postmenopausal and premenopausal women receiving LHRH analogues, ≥ 18 years. * ECOG score ≤ 2 * Histologically confirmed ER+ and/or PgR+ and HER2- locally advanced or MBC * Not candidates for a local treatment with a radical intention * No prior therapy for metastatic disease. * Evidence of measurable or evaluable metastatic disease
Participant milestones
| Measure |
Arm A
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Overall Study
STARTED
|
243
|
243
|
|
Overall Study
COMPLETED
|
241
|
242
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm A
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Not meet selection criteria
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=243 Participants
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 Participants
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
Total
n=486 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
|
142 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
243 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
486 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
|
125 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
230 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
461 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
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
29 participants
n=5 Participants
|
25 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
France
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
125 participants
n=5 Participants
|
130 participants
n=7 Participants
|
255 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPercentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)
Outcome measures
| Measure |
Arm A
n=243 Participants
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 Participants
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
1-year Progression Free Survival
|
79.4 percentage of participants
Interval 73.6 to 84.0
|
77.9 percentage of participants
Interval 72.0 to 82.8
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 51 months.Grade 3/4 adverse events, SAEs, deaths and discontinuations following the CTCAE v5 criteria
Outcome measures
| Measure |
Arm A
n=243 Participants
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 Participants
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Number of Participants With Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations •
|
243 Participants
|
243 Participants
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 51 months.Time from randomization to disease progression
Outcome measures
| Measure |
Arm A
n=243 Participants
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 Participants
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Time To Progression (TTP)
|
32.8 months
Interval 26.0 to 38.6
|
28.9 months
Interval 24.6 to 36.2
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 51 months.Time from date of randomization to date of death due to any cause
Outcome measures
| Measure |
Arm A
n=243 Participants
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 Participants
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 49.9 to
There were not enough events to calculate the OS. 50% of the patients did not die.
|
NA months
Interval 49.0 to
There were not enough events to calculate the OS. 50% of the patients did not die.
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 51 months.Percentage of patients who experience a CR, PR or stable disease (for at least 24 weeks) and assessed by modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Outcome measures
| Measure |
Arm A
n=243 Participants
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 Participants
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Clinical Benefit Rate
|
69.1 percentage of participants
Interval 62.9 to 74.9
|
70.8 percentage of participants
Interval 64.6 to 76.4
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 51 months.Proportion of patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)
Outcome measures
| Measure |
Arm A
n=243 Participants
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 Participants
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Overall Response Rate
|
112 Participants
|
106 Participants
|
Adverse Events
Arm A
Serious events: 51 serious events
Other events: 242 other events
Deaths: 2 deaths
Arm B
Serious events: 72 serious events
Other events: 241 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm A
n=243 participants at risk
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 participants at risk
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Respiratory tract infection
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Influenza
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Bacteraemia
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Diverticulitis
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Skin infection
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Device related infection
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Infection
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Pyelonephritis acute
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Rhinitis
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Sepsis
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Pulmonary embolism
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
2.5%
6/243 • Number of events 6 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Severe asthma with fungal sensitisation
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Tuberculosis
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
2.5%
6/243 • Number of events 6 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Constipation
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine neoplasm
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Aphasia
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Headache
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Migraine
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Syncope
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
2.1%
5/243 • Number of events 5 • Through study completion. From baseline up to 51 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
|
Investigations
Blood sodium decreased
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Pyrexia
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
1.2%
3/243 • Number of events 3 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Condition aggravated
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
General disorders
General physical health deterioration
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Pain
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Cardiac disorders
Angina unstable
|
0.82%
2/243 • Number of events 2 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Cardiac disorders
Cardiac failure
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Hepatobiliary disorders
Jaundice
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Reproductive system and breast disorders
Breast mass
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Product Issues
Device dislocation
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Surgical and medical procedures
Radiotherapy to bone
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
|
Surgical and medical procedures
Spinal corpectomy
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
0.41%
1/243 • Number of events 1 • Through study completion. From baseline up to 51 months.
|
Other adverse events
| Measure |
Arm A
n=243 participants at risk
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
|
Arm B
n=243 participants at risk
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
85.2%
207/243 • Number of events 207 • Through study completion. From baseline up to 51 months.
|
81.5%
198/243 • Number of events 198 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.4%
18/243 • Number of events 18 • Through study completion. From baseline up to 51 months.
|
7.4%
18/243 • Number of events 18 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.0%
39/243 • Number of events 39 • Through study completion. From baseline up to 51 months.
|
20.2%
49/243 • Number of events 49 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.1%
61/243 • Number of events 61 • Through study completion. From baseline up to 51 months.
|
24.7%
60/243 • Number of events 60 • Through study completion. From baseline up to 51 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
28.0%
68/243 • Number of events 68 • Through study completion. From baseline up to 51 months.
|
22.6%
55/243 • Number of events 55 • Through study completion. From baseline up to 51 months.
|
|
Ear and labyrinth disorders
Vertigo
|
4.1%
10/243 • Number of events 10 • Through study completion. From baseline up to 51 months.
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Toothache
|
4.5%
11/243 • Number of events 11 • Through study completion. From baseline up to 51 months.
|
3.3%
8/243 • Number of events 8 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Dry mouth
|
4.9%
12/243 • Number of events 12 • Through study completion. From baseline up to 51 months.
|
3.7%
9/243 • Number of events 9 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
1.6%
4/243 • Number of events 4 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
7.4%
18/243 • Number of events 18 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
25/243 • Number of events 25 • Through study completion. From baseline up to 51 months.
|
8.6%
21/243 • Number of events 21 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.8%
31/243 • Number of events 31 • Through study completion. From baseline up to 51 months.
|
9.1%
22/243 • Number of events 22 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
39/243 • Number of events 39 • Through study completion. From baseline up to 51 months.
|
14.4%
35/243 • Number of events 35 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Constipation
|
16.5%
40/243 • Number of events 40 • Through study completion. From baseline up to 51 months.
|
14.0%
34/243 • Number of events 34 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Nausea
|
18.5%
45/243 • Number of events 45 • Through study completion. From baseline up to 51 months.
|
23.5%
57/243 • Number of events 57 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Stomatitis
|
19.8%
48/243 • Number of events 48 • Through study completion. From baseline up to 51 months.
|
16.5%
40/243 • Number of events 40 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.7%
60/243 • Number of events 60 • Through study completion. From baseline up to 51 months.
|
26.7%
65/243 • Number of events 65 • Through study completion. From baseline up to 51 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
65.0%
158/243 • Number of events 158 • Through study completion. From baseline up to 51 months.
|
69.1%
168/243 • Number of events 168 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Injection site pain
|
0.00%
0/243 • Through study completion. From baseline up to 51 months.
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Pain
|
5.8%
14/243 • Number of events 14 • Through study completion. From baseline up to 51 months.
|
6.6%
16/243 • Number of events 16 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Oedema peripheral
|
9.1%
22/243 • Number of events 22 • Through study completion. From baseline up to 51 months.
|
7.4%
18/243 • Number of events 18 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Pyrexia
|
9.9%
24/243 • Number of events 24 • Through study completion. From baseline up to 51 months.
|
9.5%
23/243 • Number of events 23 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Fatigue
|
25.9%
63/243 • Number of events 63 • Through study completion. From baseline up to 51 months.
|
25.5%
62/243 • Number of events 62 • Through study completion. From baseline up to 51 months.
|
|
General disorders
Asthenia
|
35.8%
87/243 • Number of events 87 • Through study completion. From baseline up to 51 months.
|
37.0%
90/243 • Number of events 90 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Respiratory tract infection
|
2.9%
7/243 • Number of events 7 • Through study completion. From baseline up to 51 months.
|
5.8%
14/243 • Number of events 14 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Conjunctivitis
|
4.5%
11/243 • Number of events 11 • Through study completion. From baseline up to 51 months.
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Pharyngitis
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
1.6%
4/243 • Number of events 4 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Influenza
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
8.2%
20/243 • Number of events 20 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Bronchitis
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
5.8%
14/243 • Number of events 14 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
17/243 • Number of events 17 • Through study completion. From baseline up to 51 months.
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Urinary tract infection
|
10.7%
26/243 • Number of events 26 • Through study completion. From baseline up to 51 months.
|
9.5%
23/243 • Number of events 23 • Through study completion. From baseline up to 51 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
13.2%
32/243 • Number of events 32 • Through study completion. From baseline up to 51 months.
|
13.2%
32/243 • Number of events 32 • Through study completion. From baseline up to 51 months.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
|
Investigations
Alanine aminotransferase increased
|
6.6%
16/243 • Number of events 16 • Through study completion. From baseline up to 51 months.
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.6%
33/243 • Number of events 33 • Through study completion. From baseline up to 51 months.
|
14.0%
34/243 • Number of events 34 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
11/243 • Number of events 11 • Through study completion. From baseline up to 51 months.
|
4.9%
12/243 • Number of events 12 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.6%
16/243 • Number of events 16 • Through study completion. From baseline up to 51 months.
|
4.5%
11/243 • Number of events 11 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.8%
19/243 • Number of events 19 • Through study completion. From baseline up to 51 months.
|
9.9%
24/243 • Number of events 24 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.5%
23/243 • Number of events 23 • Through study completion. From baseline up to 51 months.
|
11.1%
27/243 • Number of events 27 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
28/243 • Number of events 28 • Through study completion. From baseline up to 51 months.
|
16.0%
39/243 • Number of events 39 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.2%
49/243 • Number of events 49 • Through study completion. From baseline up to 51 months.
|
23.5%
57/243 • Number of events 57 • Through study completion. From baseline up to 51 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.9%
80/243 • Number of events 80 • Through study completion. From baseline up to 51 months.
|
25.5%
62/243 • Number of events 62 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Paraesthesia
|
5.8%
14/243 • Number of events 14 • Through study completion. From baseline up to 51 months.
|
7.0%
17/243 • Number of events 17 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Dysgeusia
|
6.6%
16/243 • Number of events 16 • Through study completion. From baseline up to 51 months.
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Dizziness
|
8.2%
20/243 • Number of events 20 • Through study completion. From baseline up to 51 months.
|
6.6%
16/243 • Number of events 16 • Through study completion. From baseline up to 51 months.
|
|
Nervous system disorders
Headache
|
13.6%
33/243 • Number of events 33 • Through study completion. From baseline up to 51 months.
|
14.0%
34/243 • Number of events 34 • Through study completion. From baseline up to 51 months.
|
|
Psychiatric disorders
Depression
|
4.1%
10/243 • Number of events 10 • Through study completion. From baseline up to 51 months.
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
|
Psychiatric disorders
Anxiety
|
7.8%
19/243 • Number of events 19 • Through study completion. From baseline up to 51 months.
|
4.5%
11/243 • Number of events 11 • Through study completion. From baseline up to 51 months.
|
|
Psychiatric disorders
Insomnia
|
8.6%
21/243 • Number of events 21 • Through study completion. From baseline up to 51 months.
|
7.4%
18/243 • Number of events 18 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
6/243 • Number of events 6 • Through study completion. From baseline up to 51 months.
|
4.9%
12/243 • Number of events 12 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.8%
19/243 • Number of events 19 • Through study completion. From baseline up to 51 months.
|
5.8%
14/243 • Number of events 14 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.9%
29/243 • Number of events 29 • Through study completion. From baseline up to 51 months.
|
13.6%
33/243 • Number of events 33 • Through study completion. From baseline up to 51 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.3%
42/243 • Number of events 42 • Through study completion. From baseline up to 51 months.
|
22.2%
54/243 • Number of events 54 • Through study completion. From baseline up to 51 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
15/243 • Number of events 15 • Through study completion. From baseline up to 51 months.
|
10.7%
26/243 • Number of events 26 • Through study completion. From baseline up to 51 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
19/243 • Number of events 19 • Through study completion. From baseline up to 51 months.
|
3.7%
9/243 • Number of events 9 • Through study completion. From baseline up to 51 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
25/243 • Number of events 25 • Through study completion. From baseline up to 51 months.
|
11.5%
28/243 • Number of events 28 • Through study completion. From baseline up to 51 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.1%
61/243 • Number of events 61 • Through study completion. From baseline up to 51 months.
|
23.0%
56/243 • Number of events 56 • Through study completion. From baseline up to 51 months.
|
|
Vascular disorders
Hypertension
|
5.3%
13/243 • Number of events 13 • Through study completion. From baseline up to 51 months.
|
4.1%
10/243 • Number of events 10 • Through study completion. From baseline up to 51 months.
|
|
Vascular disorders
Hot flush
|
18.9%
46/243 • Number of events 46 • Through study completion. From baseline up to 51 months.
|
16.9%
41/243 • Number of events 41 • Through study completion. From baseline up to 51 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place