Study for Women and Men With Hormone-receptor Positive Lo... | NCT03096847 | Trialant
NCT03096847
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Oct 11, 2021Actual
Enrollment
502Actual
Phase
Phase 3
Conditions
Advanced Metastatic Breast Cancer
Interventions
ribociclib
letrozole
goserelin
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT03096847
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLEE011XDE01
Secondary IDs
ID
Type
Description
Link
CLEE011XDE01
Other Identifier
Novartis
2016-002556-24
EudraCT Number
Brief Title
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
Official Title
A National Phase IIIb, Multi-center, Open Label Study for Women and Men With Hormone-receptor Positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Ribociclib (LEE011) in Combination With Letrozole
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 24, 2016Actual
Primary Completion Date
Dec 11, 2018Actual
Completion Date
Feb 6, 2020Actual
First Submitted Date
Mar 10, 2017
First Submission Date that Met QC Criteria
Mar 24, 2017
First Posted Date
Mar 30, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 3, 2021
Results First Submitted that Met QC Criteria
Apr 28, 2021
Results First Posted Date
May 19, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 7, 2021
Last Update Posted Date
Oct 11, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients were treated with daily doses of 600 mg ribociclib (3-weeks-on/1-week-off schedule) in combination with 2.5 mg letrozole daily (continuous dosing). Dose adjustments (dose reduction or interruption) according to safety findings were allowed.
Detailed Description
The main purpose of this study was to collect additional efficacy and safety data for the combination of ribociclib and letrozole in a patient population broader than the MONALEESA-2 study (NCT01958021 / CLEE011A2301), and to provide access to ribociclib to patients for which available treatment options are unsatisfactory treatment alternatives until the drug is approved for this indication. Furthermore, this trial aimed to collect data for the combination of ribociclib and letrozole in the context of current local routine therapy algorithms for the treatment of metastatic and advanced breast cancer.
This multi-center, open-label, single-arm study aimed to evaluate the efficacy, safety, and quality of life for the combination of ribociclib and letrozole in a patient population than in the MONALEESA-2 study, i.e. in patients pretreated with one line of chemotherapy and/or a maximum of two lines of endocrine therapy as well as premenopausal patients, without limitations regarding the disease free interval after adjuvant therapy.
For ethical reasons no endocrine comparator drugs were investigated in this study. The duration of study treatment of 80 weeks was adequate to determine the primary, secondary and exploratory study parameters. The sample size was suitable to estimate the clinical benefit rate (CBR) in this patient population with reasonable precision.
Goserelin was used in premenopausal patients, since it was shown that ovarian suppression of estrogen release with luteinizing hormone-releasing hormone agonists (LHRHa) (such as goserelin) is effective in preventing relapse in premenopausal women with early stage ER+ breast cancer (Klijn et al. 2001).
The efficacy and safety of ribociclib in combination with letrozole for the treatment of postmenopausal women with advanced or metastatic breast cancer vs. placebo (i.e., letrozole alone) was already demonstrated in the preceding, pivotal MONALESSA-2 study. Thus, for ethical reasons no endocrine comparator drugs were investigated in the present RIBECCA study.
Generally, the single-arm, open-label design and the broadening of the study population (compared to the pivotal MONALESSA-2 study) in the RIBECCA study was deemed appropriate to further evaluate the efficacy and safety of ribociclib plus letrozole among breast cancer patients in a treatment setting closer to routine care. The duration of study treatment of up to 80 weeks was considered adequate to determine the primary, secondary and exploratory study parameters. Moreover, the sample size was suitable to estimate the CBR in this patient population with reasonable precision.
Conditions Module
Conditions
Advanced Metastatic Breast Cancer
Keywords
ribociclib
LEE011
RIBECCA
breast cancer
breast carcinoma
HR-positive
HER2-negative
advanced breast cancer
Letrozole
CDK4/6
breast lump
HER2 positive
metastatic breast cancer
breast cancer positive for human epidermal growth factor receptor 2 (HER2) HER2 positive metastatic breast cancer
breast cancer progression
estrogen-receptor (ER) positive(+) breast cancer
Paget's disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
502Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ribociclib + letrozole cohort A
Experimental
ribociclib + letrozole cohort A - postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Drug: ribociclib
Drug: letrozole
Drug: goserelin
ribociclib + letrozole cohort B1
Experimental
ribociclib + letrozole cohort B1 - premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Drug: ribociclib
Drug: letrozole
Drug: goserelin
ribociclib + letrozole cohort B2
Experimental
ribociclib + letrozole cohort B2 - premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Drug: ribociclib
Drug: letrozole
Drug: goserelin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ribociclib
Drug
All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Clinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole
Clinical Benefit Rate (CBR) after 24 weeks of treatment as defined by RECIST 1.1 as percentage of patients with Complete Response (CR), Partial response (PR) or Stable disease (SD) lasting 24 weeks or longer as well as patients with Non-complete response, nonprogressive disease (NCRNPD).
At 24 weeks after last patient enrolled in trial
Secondary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS) for Different Populations - Kaplan-Meier Estimates (%, 95% CI)
PFS based on radiologic assessment by investigator using RECIST 1.1 criteria
At week 24 , week 48 and week 72
Progression Free Survival (PFS) for Different Populations - Median Time to Progression or Death With 95% CI [Months]
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient is an adult, ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines
Women and men with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment.
Patient must have either:
Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).
Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease
Non-measurable disease
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Exclusion Criteria
Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.
Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole
Patients with current inflammatory breast cancer.
Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast cancer
Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic breast cancer
Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial.
completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study and
CNS tumor is clinically stable at the time of screening and
Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases
Patient has active cardiac disease or a history of cardiac dysfunction
Peuker CA, Yaghobramzi S, Grunert C, Keilholz L, Gjerga E, Hennig S, Schaper S, Na IK, Keller U, Brucker S, Decker T, Fasching P, Fehm T, Janni W, Kummel S, Schneeweiss A, Schuler M, Luftner D, Busse A. Treatment with ribociclib shows favourable immunomodulatory effects in patients with hormone receptor-positive breast cancer-findings from the RIBECCA trial. Eur J Cancer. 2022 Feb;162:45-55. doi: 10.1016/j.ejca.2021.11.025. Epub 2021 Dec 23.
See Also Links
Label
URL
A Plain Language Trial Summary is available on novartisclinicaltrials.com
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
504 participants were entered into the study, but 2 of these participants were not treated. The full analysis set is comprised of the 504 participants minus 17 participants, whose data were removed because of inspection findings, to equal 487 participants. This full analysis set includes the 2 participants who were entered into the study but were not treated.
502 participants were treated; these 502 participants are included in the safety set.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
FG001
Ribociclib + Letrozole Cohort B1
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
participants who started treatment
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 5, 2019
Feb 3, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
ribociclib + letrozole cohort A
ribociclib + letrozole cohort B1
ribociclib + letrozole cohort B2
LEE011
letrozole
Drug
All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
ribociclib + letrozole cohort A
ribociclib + letrozole cohort B1
ribociclib + letrozole cohort B2
goserelin
Drug
Premenopausal patients additionally received goserelin 3.6mg as monthly implant
ribociclib + letrozole cohort A
ribociclib + letrozole cohort B1
ribociclib + letrozole cohort B2
PFS based on radiologic assessment by investigator using RECIST 1.1 criteria
Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause. For the Kaplan-Meier estimates (%, 95% CI), the probability of survival at week 24, 48 and 72 is reported below.
At Week 24, Week 48 and Week 72
Overall Survival (OS) - Median Time to Progression or Death With 95% CI [Months]
Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause.
Up to approximatley 38 months
Overall Survival (OS) - Number of Censored Participants and Number of Deaths
Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause.
Overall response rate (ORR) is the best overall response (BOR) of complete response (CR) or partial response (PR) as defined by RECIST 1.1.
At week 24
Change From Baseline at Week 24 of Patient Reported Quality of Life (QoL) Via EORTC QLQ-C30
The QLQ-C30 is the core questionnaire of the EORTC QLQ, which has been developed for the assessment of the health-related QOL of cancer patients participating in international clinical trials. Using a linear transformation to standardize the raw scores, all scores finally range from 0 to 100, where a higher score represents a higher response level, e.g., a higher ("better") level of functioning (applies to the first 6 items, items 1 to 6), but a higher ("worse") level of symptoms (applies to the last 9 items, items 7 to 15). There is no aggregated total score, i.e., all scale scores were analyzed separately.
Change from Baseline to Week 24
Patient Reported Quality of Life (QoL) Via EORTC BR-23 - Change From Baseline at Week 24 (Cycle 7)
To evaluate health related quality of life (QoL) via EORTC BR-23. The scoring approach for the QLQ-BR23 is identical in principle to that for the function and symptom scales / single items of the QLQ-C30, i.e., all scores finally range from 0 to 100, where a higher score represents a higher response level, e.g., a higher ("better") level of functioning, (applies to the first 4 items, items 1 to 4) but a higher ("worse") level of symptoms (applies to the last 4 items, items 5 to 8).
Baseline and Week 24 (Cycle 7)
Time to 10% Deterioration in EORTC Global Health Status
Time to 10% deterioration in the European Organisation for Research and Treatment of Cancer (EORTC) global health status
up to approximately 10 months
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Adverse Events (AEs) were separated into TEAEs (defined as AEs occurring/worsening from first study drug treatment until 30 days after the last study drug treatment) and AEs in the pre-/post-treatment period.
Up to Week 72
Langen
Hesse
63225
Germany
Novartis Investigative Site
Recklinghausen
North Rhine-Westphalia
45657
Germany
Novartis Investigative Site
Lübeck
Schleswig-Holstein
23563
Germany
Novartis Investigative Site
Aachen
52074
Germany
Novartis Investigative Site
Augsburg
86150
Germany
Novartis Investigative Site
Berlin
10117
Germany
Novartis Investigative Site
Berlin
10367
Germany
Novartis Investigative Site
Berlin
10713
Germany
Novartis Investigative Site
Berlin
10967
Germany
Novartis Investigative Site
Berlin
13353
Germany
Novartis Investigative Site
Berlin
13581
Germany
Novartis Investigative Site
Berlin
14195
Germany
Novartis Investigative Site
Bielefeld
33604
Germany
Novartis Investigative Site
Bonn
53111
Germany
Novartis Investigative Site
Bottrop
46236
Germany
Novartis Investigative Site
Böblingen
71032
Germany
Novartis Investigative Site
Chemnitz
09113
Germany
Novartis Investigative Site
Cologne
50935
Germany
Novartis Investigative Site
Dessau
06847
Germany
Novartis Investigative Site
Dresden
01307
Germany
Novartis Investigative Site
Düsseldorf
40225
Germany
Novartis Investigative Site
Düsseldorf
40479
Germany
Novartis Investigative Site
Erlangen
91054
Germany
Novartis Investigative Site
Essen
45136
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Esslingen am Neckar
73730
Germany
Novartis Investigative Site
Frankfurt
60398
Germany
Novartis Investigative Site
Frankfurt
60431
Germany
Novartis Investigative Site
Freiburg im Breisgau
79106
Germany
Novartis Investigative Site
Fürstenwalde
15517
Germany
Novartis Investigative Site
Fürth
90766
Germany
Novartis Investigative Site
Georgsmarienhütte
49124
Germany
Novartis Investigative Site
Goslar
38642
Germany
Novartis Investigative Site
Göttingen
37073
Germany
Novartis Investigative Site
Greifswald
17475
Germany
Novartis Investigative Site
Hamburg
20246
Germany
Novartis Investigative Site
Hamburg
22081
Germany
Novartis Investigative Site
Hamburg
22767
Germany
Novartis Investigative Site
Hanover
30177
Germany
Novartis Investigative Site
Hanover
30559
Germany
Novartis Investigative Site
Hanover
30625
Germany
Novartis Investigative Site
Heidelberg
69115
Germany
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Hildesheim
31134
Germany
Novartis Investigative Site
Homburg
66421
Germany
Novartis Investigative Site
Jena
07740
Germany
Novartis Investigative Site
Kiel
24103
Germany
Novartis Investigative Site
Kiel
24105
Germany
Novartis Investigative Site
Kulmbach
95326
Germany
Novartis Investigative Site
Landshut
84028
Germany
Novartis Investigative Site
Leer
26789
Germany
Novartis Investigative Site
Leipzig
04103
Germany
Novartis Investigative Site
Leipzig
04277
Germany
Novartis Investigative Site
Mannheim
68165
Germany
Novartis Investigative Site
Marburg
35037
Germany
Novartis Investigative Site
Minden
32429
Germany
Novartis Investigative Site
Mönchengladbach
41061
Germany
Novartis Investigative Site
München
80637
Germany
Novartis Investigative Site
Münster
48145
Germany
Novartis Investigative Site
Münster
48149
Germany
Novartis Investigative Site
Neuruppin
16816
Germany
Novartis Investigative Site
Nuremberg
90419
Germany
Novartis Investigative Site
Offenbach
63069
Germany
Novartis Investigative Site
Oldenburg
26121
Germany
Novartis Investigative Site
Passau
94032
Germany
Novartis Investigative Site
Potsdam
14467
Germany
Novartis Investigative Site
Ravensburg
88214
Germany
Novartis Investigative Site
Rotenburg (Wümme)
27356
Germany
Novartis Investigative Site
Saarbrücken
66113
Germany
Novartis Investigative Site
Schweinfurt
97422
Germany
Novartis Investigative Site
Stuttgart
70199
Germany
Novartis Investigative Site
Suhl
98527
Germany
Novartis Investigative Site
Torgau
04860
Germany
Novartis Investigative Site
Trier
54290
Germany
Novartis Investigative Site
Troisdorf
53840
Germany
Novartis Investigative Site
Tübingen
72076
Germany
Novartis Investigative Site
Ulm
89081
Germany
Novartis Investigative Site
Velbert
42551
Germany
Novartis Investigative Site
Völklingen
66333
Germany
Novartis Investigative Site
Weinheim
69469
Germany
Novartis Investigative Site
Wetzlar
35578
Germany
Novartis Investigative Site
Wiesbaden
65191
Germany
Novartis Investigative Site
Würzburg
97080
Germany
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
FG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
FG000319 subjects
FG00126 subjects
FG002157 subjects
Full Analysis Set
FG000307 subjects
FG00126 subjects
FG002154 subjects
COMPLETED
Completed study
FG000100 subjectsOnly the primary reason for disc. is included in this table.
FG0016 subjectsOnly the primary reason for disc. is included in this table.
FG00219 subjectsOnly the primary reason for disc. is included in this table.
NOT COMPLETED
FG000219 subjects
FG00120 subjects
FG002138 subjects
Type
Comment
Reasons
Other
FG0002 subjects
FG0011 subjects
FG0022 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
Death
FG0006 subjects
FG0010 subjects
FG0022 subjects
Protocol Violation
FG0003 subjects
FG0010 subjects
FG0026 subjects
Physician Decision
FG00012 subjects
FG0012 subjects
FG0028 subjects
Withdrawal by Subject
FG00024 subjects
FG0011 subjects
FG00212 subjects
Adverse Event
FG00072 subjects
FG0016 subjects
FG00228 subjects
Progressive disease
FG00097 subjects
FG00110 subjects
FG00278 subjects
Non-compliance with study medication
FG0001 subjects
FG0010 subjects
FG0020 subjects
New therapy for study indication
FG0001 subjects
FG0010 subjects
FG0021 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
BG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
BG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000319
BG00126
BG002157
BG003502
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00065.7± 10.1
BG00146.5± 4.9
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000315
BG00126
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Clinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole
Clinical Benefit Rate (CBR) after 24 weeks of treatment as defined by RECIST 1.1 as percentage of patients with Complete Response (CR), Partial response (PR) or Stable disease (SD) lasting 24 weeks or longer as well as patients with Non-complete response, nonprogressive disease (NCRNPD).
Full Analysis Set. Please note that the statistical significance test (test comparing groups) i.e., statistical analysis was not applicable for this outcome measure, since the primary objective was to assess the rate (per cohort) and not to compare two or more treatment arms, as this was a non-randomized, single arm open label trial.
Posted
Number
95% Confidence Interval
Percentage of Participants
At 24 weeks after last patient enrolled in trial
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG003
Total
Cohort A and Cohort B combined
Units
Counts
Participants
OG000307
OG00126
OG002154
OG003
Title
Denominators
Categories
CBR by week 24 (= BOR of CR or PR or SD or NCRNPD(Confirmed Best Overall Response (BOR))
Title
Measurements
OG00063.2(57.5 to 68.6)
OG00157.7(36.9 to 76.6)
OG00256.5(48.3 to 64.5)
Secondary
Progression Free Survival (PFS) for Different Populations - Kaplan-Meier Estimates (%, 95% CI)
PFS based on radiologic assessment by investigator using RECIST 1.1 criteria
Full Analysis Set
Posted
Number
95% Confidence Interval
Percentage of Participants
At week 24 , week 48 and week 72
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Secondary
Progression Free Survival (PFS) for Different Populations - Median Time to Progression or Death With 95% CI [Months]
PFS based on radiologic assessment by investigator using RECIST 1.1 criteria
Full Analysis Set
Posted
Median
95% Confidence Interval
Months
Up to approximately month 25
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause. For the Kaplan-Meier estimates (%, 95% CI), the probability of survival at week 24, 48 and 72 is reported below.
Full Analysis Set
Posted
Number
95% Confidence Interval
Percentage of Participants
At Week 24, Week 48 and Week 72
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Secondary
Overall Survival (OS) - Median Time to Progression or Death With 95% CI [Months]
Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause.
Full Analysis Set
Posted
Median
95% Confidence Interval
Months
Up to approximatley 38 months
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Secondary
Overall Survival (OS) - Number of Censored Participants and Number of Deaths
Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause.
Full Analysis Set
Posted
Number
Participants
Up to approximatley 38 months
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Overall response rate (ORR) is the best overall response (BOR) of complete response (CR) or partial response (PR) as defined by RECIST 1.1.
Full Analysis Set
Posted
Number
95% Confidence Interval
Percentage of Participants
At week 24
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Secondary
Change From Baseline at Week 24 of Patient Reported Quality of Life (QoL) Via EORTC QLQ-C30
The QLQ-C30 is the core questionnaire of the EORTC QLQ, which has been developed for the assessment of the health-related QOL of cancer patients participating in international clinical trials. Using a linear transformation to standardize the raw scores, all scores finally range from 0 to 100, where a higher score represents a higher response level, e.g., a higher ("better") level of functioning (applies to the first 6 items, items 1 to 6), but a higher ("worse") level of symptoms (applies to the last 9 items, items 7 to 15). There is no aggregated total score, i.e., all scale scores were analyzed separately.
Full Analysis Set. Included in the analysis are all patients with valid assessment at baseline and week 24. Some questions were conditional branching and thus did not apply to some participants. Also, some participants chose not to answer some questions / items; the responses were accepted as provided by the participants. Also, some participants discontinued during the course of the trial, and thus less measurements were taken at week 24 than at baseline.
Posted
Mean
Standard Deviation
Scores on a scale
Change from Baseline to Week 24
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
Secondary
Patient Reported Quality of Life (QoL) Via EORTC BR-23 - Change From Baseline at Week 24 (Cycle 7)
To evaluate health related quality of life (QoL) via EORTC BR-23. The scoring approach for the QLQ-BR23 is identical in principle to that for the function and symptom scales / single items of the QLQ-C30, i.e., all scores finally range from 0 to 100, where a higher score represents a higher response level, e.g., a higher ("better") level of functioning, (applies to the first 4 items, items 1 to 4) but a higher ("worse") level of symptoms (applies to the last 4 items, items 5 to 8).
Full Analysis Set. Included in the analysis are all patients with valid assessment at baseline and week 24. Some questions were conditional branching and thus did not apply to some participants. Also, some participants chose not to answer some questions / items; the responses were accepted as provided by the participants. Also, some participants discontinued during the course of the trial, and thus less measurements were taken at week 24 than at baseline.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline and Week 24 (Cycle 7)
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Secondary
Time to 10% Deterioration in EORTC Global Health Status
Time to 10% deterioration in the European Organisation for Research and Treatment of Cancer (EORTC) global health status
Full Analysis Set
Posted
Median
95% Confidence Interval
months
up to approximately 10 months
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG003
Total
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Adverse Events (AEs) were separated into TEAEs (defined as AEs occurring/worsening from first study drug treatment until 30 days after the last study drug treatment) and AEs in the pre-/post-treatment period.
Safety Set
Posted
Number
Number of Participants
Up to Week 72
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Post-Hoc
All Collected Deaths
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 1150 days (approx 3.15 years). (Treatment duration ranged from 2 days to 1120 days). Deaths post treatment survival follow up were collected after the on- treatment period, up to approx. 3.15 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.
Clinical database population - all treated participants
Posted
Number
Participants
on-treatment deaths: up to approx 3.15 years; all deaths: approx 3.15 years
ID
Title
Description
OG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
OG001
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally rec
Time Frame
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 1150 days (approx. 3.15 years).(Treatment duration ranged from 2 days to 1120 days.)
Description
For this study, disease progression was NOT classified as an Adverse Event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Ribociclib + Letrozole Cohort A
postmenopausal women, or men; naïve.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
6
319
97
319
315
319
EG001
Ribociclib + Letrozole Cohort B
premenopausal women or perimenopausal women or postmenopausal women, or men; naïve + pre-treated
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o.daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
6
183
50
183
181
183
EG002
Ribociclib + Letrozole Cohort B1
premenopausal women or perimenopausal women; naïve
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
0
26
5
26
25
26
EG003
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated.
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
6
157
45
157
156
157
EG004
Total
Total
12
502
147
502
496
502
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0004 affected319 at risk
EG0014 affected183 at risk
EG0020 affected26 at risk
EG0034 affected157 at risk
EG0048 affected502 at risk
DISSEMINATED INTRAVASCULAR COAGULATION
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0013 affected183 at risk
EG0021 affected26 at risk
EG003
HYPERFIBRINOLYSIS
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
PANCYTOPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
BRADYARRHYTHMIA
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CARDIAC ARREST
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CARDIAC FAILURE
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
HYPERTHYROIDISM
Endocrine disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
ANAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ILEUS
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
INTESTINAL STRANGULATION
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0007 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CHEST PAIN
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
COMPLICATION OF DEVICE INSERTION
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
DEATH
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
FATIGUE
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0015 affected183 at risk
EG0020 affected26 at risk
EG003
IMPAIRED HEALING
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PAIN
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
PYREXIA
General disorders
MedDRA (22.1)
Systematic Assessment
EG0006 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
BILE DUCT STENOSIS
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
BILIARY COLIC
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
DRUG-INDUCED LIVER INJURY
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0005 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HEPATIC CIRRHOSIS
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HEPATOTOXICITY
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
JAUNDICE
Hepatobiliary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ABDOMINAL ABSCESS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ABSCESS JAW
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
ATYPICAL PNEUMONIA
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CHOLECYSTITIS INFECTIVE
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
CYSTITIS ESCHERICHIA
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
EMPHYSEMATOUS CHOLECYSTITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ERYSIPELAS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ESCHERICHIA INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
FEBRILE INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
GASTROINTESTINAL INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HELICOBACTER GASTRITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
INFECTIOUS PLEURAL EFFUSION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
MASTITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0008 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
PROTEUS INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
SEPSIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ACCIDENT
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0021 affected26 at risk
EG003
CERVICAL VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
FEMORAL NECK FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HUMERUS FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
INCISIONAL HERNIA
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
JAW FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0021 affected26 at risk
EG003
POST-TRAUMATIC PAIN
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
POSTOPERATIVE ADHESION
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PROCEDURAL COMPLICATION
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
RADIUS FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
TIBIA FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
UPPER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0005 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0021 affected26 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0021 affected26 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
HYPOPHAGIA
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
BONE LESION
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0012 affected183 at risk
EG0020 affected26 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
MOBILITY DECREASED
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
OSTEITIS
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
OSTEONECROSIS OF JAW
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
BRONCHIAL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CANCER PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
COLON CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
MALIGNANT PLEURAL EFFUSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
METASTASES TO BONE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
METASTASES TO SPINE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
RENAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
SQUAMOUS CELL CARCINOMA OF THE TONGUE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0021 affected26 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
CEREBRAL ISCHAEMIA
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
CEREBROVASCULAR ACCIDENT
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
MONOPLEGIA
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PERIPHERAL NERVE LESION
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
DEVICE LOOSENING
Product Issues
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
PANIC ATTACK
Psychiatric disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
SOMATIC SYMPTOM DISORDER
Psychiatric disorders
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0005 affected319 at risk
EG0011 affected183 at risk
EG0021 affected26 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
KIDNEY CONGESTION
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
RENAL DISORDER
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
URETERIC STENOSIS
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
URETEROLITHIASIS
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
URINARY TRACT OBSTRUCTION
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0009 affected319 at risk
EG0013 affected183 at risk
EG0020 affected26 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
HYPERVENTILATION
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0013 affected183 at risk
EG0020 affected26 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0007 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
PULMONARY FIBROSIS
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
CIRCULATORY COLLAPSE
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
HYPERTENSIVE CRISIS
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected319 at risk
EG0010 affected183 at risk
EG0020 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG00046 affected319 at risk
EG00136 affected183 at risk
EG0027 affected26 at risk
EG00329 affected157 at risk
EG00482 affected502 at risk
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG00076 affected319 at risk
EG00139 affected183 at risk
EG0028 affected26 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0007 affected319 at risk
EG0012 affected183 at risk
EG0022 affected26 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG000162 affected319 at risk
EG00188 affected183 at risk
EG00215 affected26 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG00026 affected319 at risk
EG00118 affected183 at risk
EG0021 affected26 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA (22.1)
Systematic Assessment
EG00033 affected319 at risk
EG00117 affected183 at risk
EG0024 affected26 at risk
EG003
DRY EYE
Eye disorders
MedDRA (22.1)
Systematic Assessment
EG00023 affected319 at risk
EG00110 affected183 at risk
EG0022 affected26 at risk
EG003
LACRIMATION INCREASED
Eye disorders
MedDRA (22.1)
Systematic Assessment
EG00034 affected319 at risk
EG00111 affected183 at risk
EG0022 affected26 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00015 affected319 at risk
EG00114 affected183 at risk
EG0025 affected26 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00033 affected319 at risk
EG00113 affected183 at risk
EG0023 affected26 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00062 affected319 at risk
EG00132 affected183 at risk
EG0024 affected26 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00085 affected319 at risk
EG00140 affected183 at risk
EG0028 affected26 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00028 affected319 at risk
EG00110 affected183 at risk
EG0021 affected26 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00025 affected319 at risk
EG00114 affected183 at risk
EG0022 affected26 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG000130 affected319 at risk
EG00177 affected183 at risk
EG0029 affected26 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00033 affected319 at risk
EG00127 affected183 at risk
EG0024 affected26 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0009 affected319 at risk
EG0014 affected183 at risk
EG0022 affected26 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG00066 affected319 at risk
EG00131 affected183 at risk
EG0025 affected26 at risk
EG003
FATIGUE
General disorders
MedDRA (22.1)
Systematic Assessment
EG000123 affected319 at risk
EG00174 affected183 at risk
EG00215 affected26 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (22.1)
Systematic Assessment
EG00035 affected319 at risk
EG00122 affected183 at risk
EG0025 affected26 at risk
EG003
PYREXIA
General disorders
MedDRA (22.1)
Systematic Assessment
EG00023 affected319 at risk
EG00114 affected183 at risk
EG0024 affected26 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA (22.1)
Systematic Assessment
EG0004 affected319 at risk
EG0016 affected183 at risk
EG0023 affected26 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG00019 affected319 at risk
EG0015 affected183 at risk
EG0021 affected26 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG00021 affected319 at risk
EG0019 affected183 at risk
EG0023 affected26 at risk
EG003
GASTROINTESTINAL INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0002 affected319 at risk
EG0013 affected183 at risk
EG0022 affected26 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG00094 affected319 at risk
EG00149 affected183 at risk
EG00210 affected26 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG00031 affected319 at risk
EG00117 affected183 at risk
EG0021 affected26 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0013 affected183 at risk
EG0022 affected26 at risk
EG003
ARTHROPOD STING
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0012 affected183 at risk
EG0022 affected26 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00075 affected319 at risk
EG00136 affected183 at risk
EG0026 affected26 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00066 affected319 at risk
EG00136 affected183 at risk
EG0025 affected26 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00016 affected319 at risk
EG0011 affected183 at risk
EG0020 affected26 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00027 affected319 at risk
EG00112 affected183 at risk
EG0022 affected26 at risk
EG003
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00017 affected319 at risk
EG0013 affected183 at risk
EG0021 affected26 at risk
EG003
BLOOD THYROID STIMULATING HORMONE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected319 at risk
EG0012 affected183 at risk
EG0022 affected26 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00023 affected319 at risk
EG00114 affected183 at risk
EG0021 affected26 at risk
EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00033 affected319 at risk
EG00118 affected183 at risk
EG0025 affected26 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00040 affected319 at risk
EG00125 affected183 at risk
EG0022 affected26 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00016 affected319 at risk
EG0019 affected183 at risk
EG0020 affected26 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG0007 affected319 at risk
EG0014 affected183 at risk
EG0022 affected26 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA (22.1)
Systematic Assessment
EG00027 affected319 at risk
EG00118 affected183 at risk
EG0022 affected26 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG00044 affected319 at risk
EG00119 affected183 at risk
EG0021 affected26 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0006 affected319 at risk
EG0014 affected183 at risk
EG0022 affected26 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0008 affected319 at risk
EG0015 affected183 at risk
EG0022 affected26 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00057 affected319 at risk
EG00139 affected183 at risk
EG0029 affected26 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00037 affected319 at risk
EG00124 affected183 at risk
EG0024 affected26 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00035 affected319 at risk
EG00115 affected183 at risk
EG0026 affected26 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00012 affected319 at risk
EG0016 affected183 at risk
EG0022 affected26 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00021 affected319 at risk
EG00114 affected183 at risk
EG0022 affected26 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00018 affected319 at risk
EG0016 affected183 at risk
EG0020 affected26 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00052 affected319 at risk
EG00123 affected183 at risk
EG0023 affected26 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG00026 affected319 at risk
EG00112 affected183 at risk
EG0024 affected26 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG00020 affected319 at risk
EG00111 affected183 at risk
EG0024 affected26 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG00056 affected319 at risk
EG00136 affected183 at risk
EG00210 affected26 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected319 at risk
EG0015 affected183 at risk
EG0023 affected26 at risk
EG003
POLYNEUROPATHY
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG00016 affected319 at risk
EG0015 affected183 at risk
EG0021 affected26 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (22.1)
Systematic Assessment
EG0007 affected319 at risk
EG0018 affected183 at risk
EG0022 affected26 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (22.1)
Systematic Assessment
EG00031 affected319 at risk
EG00126 affected183 at risk
EG0024 affected26 at risk
EG003
SLEEP DISORDER
Psychiatric disorders
MedDRA (22.1)
Systematic Assessment
EG00013 affected319 at risk
EG00110 affected183 at risk
EG0024 affected26 at risk
EG003
VULVOVAGINAL DRYNESS
Reproductive system and breast disorders
MedDRA (22.1)
Systematic Assessment
EG0004 affected319 at risk
EG0013 affected183 at risk
EG0023 affected26 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG00053 affected319 at risk
EG00122 affected183 at risk
EG0026 affected26 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG00049 affected319 at risk
EG00125 affected183 at risk
EG0024 affected26 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG00011 affected319 at risk
EG0017 affected183 at risk
EG0025 affected26 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG000119 affected319 at risk
EG00157 affected183 at risk
EG0025 affected26 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00024 affected319 at risk
EG00115 affected183 at risk
EG0023 affected26 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0009 affected319 at risk
EG00110 affected183 at risk
EG0021 affected26 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00045 affected319 at risk
EG00118 affected183 at risk
EG0023 affected26 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG00047 affected319 at risk
EG00119 affected183 at risk
EG0022 affected26 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG00044 affected319 at risk
EG00130 affected183 at risk
EG00211 affected26 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG00036 affected319 at risk
EG00111 affected183 at risk
EG0024 affected26 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Hormones, Hormone Substitutes, and Hormone Antagonists
D009479
Neuropeptides
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D009842
Oligopeptides
D009419
Nerve Tissue Proteins
D011506
Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
0
Between 18 and 65 years
BG000143
BG00126
BG00287
BG003256
>=65 years
BG000176
BG0010
BG00270
BG003246
62.8
± 12.8
BG00363.8± 11.6
156
BG003497
Male
BG0004
BG0010
BG0021
BG0035
0
BG0030
Asian
BG0000
BG0011
BG0021
BG0032
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0000
BG0011
BG0020
BG0031
White
BG000312
BG00124
BG002151
BG003487
More than one race
BG0001
BG0010
BG0023
BG0034
Unknown or Not Reported
BG0006
BG0010
BG0022
BG0038
487
OG00360.8(56.3 to 65.1)
CBR by week 24 (= BOR of CR or PR or SD or NCRNPD (non-confirmed BOR)
Title
Measurements
OG00071.7(66.3 to 76.6)
OG00169.2(48.2 to 85.7)
OG00264.3(56.2 to 71.8)
OG00369.2(64.9 to 73.3)
Units
Counts
Participants
OG000307
OG00126
OG002154
Title
Denominators
Categories
Kaplan-Meier estimates (%, 95% CI) - Week 24
Title
Measurements
OG00073.1(67.3 to 77.9)
OG00167.0(44.7 to 82.0)
OG00263.8(55.2 to 71.3)
Kaplan-Meier estimates (%, 95% CI) - Week 48
Title
Measurements
OG00061.9(55.7 to 67.5)
OG00158.7(36.8 to 75.2)
OG00247.5(38.7 to 55.7)
Kaplan-Meier estimates (%, 95% CI) - week 72
Title
Measurements
OG00054.5(48.1 to 60.5)
OG00149.6(28.6 to 67.6)
OG00239.3(30.8 to 47.6)
Units
Counts
Participants
OG000307
OG00126
OG002154
Title
Denominators
Categories
Title
Measurements
OG00021.8(13.9 to 25.3)
OG00116.5(3.2 to NA)The upper limit was not estimable. Existence of the confidence limits does not directly depend on the Kaplan-Meier curve itself (dropping below 0.75, 0.5 or 0.25), but on the curves that represent the confidence limits (CL) for the survivor function. They envelop the Kaplan-Meier curve.
OG0028.8(8.1 to 16.3)
Units
Counts
Participants
OG000307
OG00126
OG002154
Title
Denominators
Categories
Kaplan-Meier estimates (%, 95% CI) - Week 24
Title
Measurements
OG00098.6(96.4 to 99.5)
OG001100.0(100.0 to 100.0)
OG00293.9(88.5 to 96.8)
Kaplan-Meier estimates (%, 95% CI) - Week 48
Title
Measurements
OG00093.3(89.7 to 95.7)
OG00187.5(66.1 to 95.8)
OG00286.1(79.2 to 90.8)
Kaplan-Meier estimates (%, 95% CI) - Week 72
Title
Measurements
OG00089.7(85.5 to 92.7)
OG00187.5(66.1 to 95.8)
OG00281.0(73.5 to 86.6)
Units
Counts
Participants
OG000307
OG00126
OG002154
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimable. Existence of the confidence limits does not directly depend on the Kaplan-Meier curve itself (dropping below 0.75, 0.5 or 0.25), but on the curves that represent the confidence limits (CL) for the survivor function. They envelop the Kaplan-Meier curve.
OG001NA(30.9 to NA)Not estimable. Existence of the confidence limits does not directly depend on the Kaplan-Meier curve itself (dropping below 0.75, 0.5 or 0.25), but on the curves that represent the confidence limits (CL) for the survivor function. They envelop the Kaplan-Meier curve.
OG002NA(31.0 to NA)Not estimable. Existence of the confidence limits does not directly depend on the Kaplan-Meier curve itself (dropping below 0.75, 0.5 or 0.25), but on the curves that represent the confidence limits (CL) for the survivor function. They envelop the Kaplan-Meier curve.
Units
Counts
Participants
OG000307
OG00126
OG002154
Title
Denominators
Categories
No. of censored (no death), n
Title
Measurements
OG000240
OG00117
OG00294
No. of events (deaths due to any cause), n
Title
Measurements
OG00067
OG0019
OG00260
Units
Counts
Participants
OG000307
OG00126
OG002154
Title
Denominators
Categories
ORR by week 24 - (BOR of CR or PR) (confirmed)
Title
Measurements
OG00022.8(18.2 to 27.9)
OG00123.1(9.0 to 43.6)
OG00211.7(7.1 to 17.8)
ORR by week 24 - (BOR of CR or PR) (unconfirmed)
Title
Measurements
OG00024.8(20.0 to 30.0)
OG00130.8(14.3 to 51.8)
OG00216.2(10.8 to 23.0)
premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG003
Ribociclib + Letrozole Cohort B
premenopausal women or perimenopausal women or postmenopausal women, or men; naïve + pre-treated
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o.daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Units
Counts
Participants
OG000307
OG00126
OG002154
OG003180
Title
Denominators
Categories
Global health status - Change from baseline to Week 24 (C7D1)
ParticipantsOG000181
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG00390
Title
Measurements
OG0008.8± 23.7
OG00111.7± 20.8
OG0025.0± 26.2
OG003
Physical Functioning - Change from baseline to Week 24 (C7D1)
ParticipantsOG000183
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Role Functioning - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Emotional Functioning - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Cognitive Functioning - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Social Functioning - Change from baseline to Week 24 (C7D1)
ParticipantsOG000181
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Fatigue - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Nausea / Vomiting - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Pain - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00274
ParticipantsOG00389
Dyspnoea - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Insomnia - Change from baseline to Week 24 (C7D1)
ParticipantsOG000183
ParticipantsOG00115
ParticipantsOG00275
ParticipantsOG003
Appetite loss - Change from baseline to Week 24 (C7D1)
ParticipantsOG000181
ParticipantsOG00115
ParticipantsOG00274
ParticipantsOG003
Constipation - Change from baseline to Week 24 (C7D1)
ParticipantsOG000183
ParticipantsOG00115
ParticipantsOG00274
ParticipantsOG003
Diarrhea - Change from baseline to Week 24 (C7D1)
ParticipantsOG000182
ParticipantsOG00115
ParticipantsOG00274
ParticipantsOG003
Financial Problems - Change from baseline to Week 24 (C7D1)
ParticipantsOG000179
ParticipantsOG00115
ParticipantsOG00273
ParticipantsOG003
OG002
Ribociclib + Letrozole Cohort B2
premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
OG003
Ribociclib + Letrozole Cohort B
premenopausal women or perimenopausal women or postmenopausal women, or men; naïve + pre-treated
All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o.daily.
Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly
Units
Counts
Participants
OG000307
OG00126
OG002154
OG003180
Title
Denominators
Categories
EORTC QLQ-BR23 BODY IMAGE during the study - change from baseline at cycle 7
ParticipantsOG000167
ParticipantsOG00115
ParticipantsOG00272
ParticipantsOG00387
Title
Measurements
OG000-1.5± 18.2
OG001-0.6± 22.2
OG0020.4± 22.7
OG003
EORTC QLQ-BR23 SEXUAL FUNCTIONING during the study - change from baseline at cycle 7
ParticipantsOG000120
ParticipantsOG00113
ParticipantsOG00260
ParticipantsOG003
EORTC QLQ-BR23 SEXUAL ENJOYMENT during the study - change from baseline at cycle 7
ParticipantsOG00018
ParticipantsOG0012
ParticipantsOG00218
ParticipantsOG003
EORTC QLQ-BR23 FUTURE PERSPECTIVE during the study - change from baseline at cycle 7
ParticipantsOG000172
ParticipantsOG00115
ParticipantsOG00274
ParticipantsOG003
EORTC QLQ-BR23 SYSTEMATIC THERAPY during the study - change from baseline at cycle 7
ParticipantsOG000180
ParticipantsOG00115
ParticipantsOG00274
ParticipantsOG003
EORTC QLQ-BR23 BREAST SYMPTOMS during the study - change from baseline at cycle 7
ParticipantsOG000172
ParticipantsOG00115
ParticipantsOG00273
ParticipantsOG003
EORTC QLQ-BR23 ARM SYMPTOMS during the study - change from baseline at cycle 7
ParticipantsOG000175
ParticipantsOG00115
ParticipantsOG00274
ParticipantsOG003
EORTC QLQ-BR23 HAIR LOSS during the study - change from baseline at cycle 7