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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000617-43 | EudraCT Number |
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The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
This study was a randomized, phase III, double-blind, placebo-controlled international trial aimed at determining the efficacy and safety of treatment with fulvestrant in combination with ribociclib compared to fulvestrant with placebo in men and postmenopausal women diagnosed with HR+, HER2-negative advanced breast cancer. The study comprised four phases: screening (up to 28 days), randomized treatment, post-treatment disease progression follow-up, and post-treatment survival follow-up.
Enrolled participants were randomly assigned to receive either fulvestrant+ribociclib or fulvestrant+placebo in a ratio of 2:1. The randomization process was stratified based on the presence of liver and/or lung metastases (yes versus no) and prior endocrine therapy. Treatment was administered until disease progression, occurrence of unacceptable toxicity, or discontinuation from the study treatment for other reasons.
Participants who discontinued treatment due to reasons other than disease progression or withdrawal of consent for efficacy follow-up continued to be monitored until disease progression, death, withdrawal of consent, loss to follow-up, or subject/guardian decision.
All participants who discontinued treatment were followed for survival until the predetermined number of overall survival (OS) events was reached.
A protocol amendment 4 (dated 29-Jan-2020) allowed for unblinding of study participants, and those still receiving placebo had the option to switch to the ribociclib arm. The decision for crossover was made at the investigator's discretion and required patient consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribociclib + fulvestrant | Experimental | Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment. |
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| Placebo + fulvestrant | Placebo Comparator | Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribociclib | Drug | Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Per Investigator Assessment | PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. The distribution of PFS between the two arms was compared using a stratified log-rank test at a one-sided 2.5% level of significance. The PFS hazard ratio with two-sided 95% confidence interval was derived from the stratified Cox proportional hazards model. | From randomization to first documented progression or death, assessed up to approximately 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status. As per protocol, the final OS analysis was conducted after approximately 351 deaths were documented. OS was estimated using the Kaplan-Meier method. The median OS, along with 95% confidence intervals (CIs), was reported for each treatment group. The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI. |
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Key Inclusion Criteria:
Patients were adults, both male and female, aged ≥ 18 years at the time of providing informed consent. Female patients were required to be postmenopausal. Informed consent was obtained prior to any trial-related activities, following local guidelines.
Patients had a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer, determined through histological and/or cytological examination by a local laboratory. Patients also had HER2-negative breast cancer.
Patients had either measurable disease as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion.
Patients had advanced breast cancer, which included locoregionally recurrent disease not amenable to curative therapies (such as surgery or radiotherapy) or metastatic breast cancer. Patients fell into one of the following categories:
Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patients had adequate bone marrow and organ function.
Key Exclusion Criteria:
Patients with symptomatic visceral disease or disease burden that rendered them ineligible for endocrine therapy, based on the investigator's judgment.
2. Patients who had received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, or any CDK4/6 inhibitor.
3. Patients with inflammatory breast cancer at the screening stage. 4. Patients with central nervous system (CNS) involvement, unless they were at least 4 weeks from completing prior therapy before initiating the study treatment and had a stable CNS tumor at the time of screening. They were also required not to be receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
5. Patients with clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
6. Patients who were currently receiving any of the following substances, which could not be discontinued 7 days prior to initiating treatment:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center PC SC-2 | Mobile | Alabama | 36608 | United States | ||
| Ironwood Cancer and Research Centers SC-2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42334791 | Derived | Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Jun 23. doi: 10.1007/s40262-026-01643-3. Online ahead of print. | |
| 39826197 | Derived | Hart LL, Im SA, Tolaney SM, Campone M, Pluard T, Sousa B, Freyer G, Decker T, Kalinsky K, Sopher G, Gao M, Hu H, Kuemmel S. Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials. Eur J Cancer. 2025 Feb 25;217:115225. doi: 10.1016/j.ejca.2025.115225. Epub 2025 Jan 8. |
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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 expert 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.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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Screening assessments were conducted up to 28 days prior to the randomization
174 sites across 30 countries enrolled participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Ribociclib + Fulvestrant | Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2020 | Nov 2, 2023 |
Following protocol amendment 4 (29-Jan-2020), study participants were unblinded, with an opportunity for those patients still in the study in the arm of placebo + fulvestrant to transition to the treatment of ribociclib + fulvestrant.
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| Fulvestrant | Drug | Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15. |
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| Placebo | Drug | Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle. |
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| From randomization to death, assessed up to approximately 46 months |
| Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC) | PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via BIRC assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. | From randomization to first documented progression or death, assessed up to approximately 26 months |
| Overall Response Rate (ORR) Per Investigator Assessment | ORR was defined as the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per investigator assessment. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Up to approximately 26 months |
| Clinical Benefit Rate (CBR) Per Investigator Assessment | CBR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 as per investigator assessment. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Up to approximately 26 months |
| Time to Response (TTR) Per Investigator Assessment | TTR was defined as the time from randomization to the first documented and confirmed response (CR or PR) as defined by RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate TTR, and the median TTR, along with 95% confidence intervals, was reported for each treatment group. Participants who did not achieve a confirmed response were censored at the maximum follow-up time for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | From randomization to first response, assessed up to approximately 26 months |
| Duration of Response (DOR) Per Investigator Assessment | DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | From first documented response to progression or death, assessed up to approximately 26 months |
| Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) in One Score Category | ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment. | Up to approximately 26 months |
| Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30) | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, a GHS/QoL scale, and 6 single items. GHS/QoL scale scores range between 0 and 100. A high score for GHS/QoL represents better functioning or QoL. The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation. | Up to approximately 26 months |
| Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30 | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, a GHS/QoL scale, and 6 single items. GHS/QoL scale scores range between 0 and 100. A high score for GHS/QoL represents better functioning or QoL. The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression. | Baseline, every 8 weeks after randomization during 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 months |
| Ribociclib Plasma Concentrations | Blood samples were collected to assess the concentration by time point for ribociclib. Participants were classified into the following dose groups at each timepoint: 1) ribociclib 600 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 600 mg immediately prior to the blood collection without a dose change or interruption. 2) ribociclib 400 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 400 mg immediately prior to the blood collection without a dose change or interruption. 3) ribociclib 200 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 200 mg immediately prior to the blood collection without a dose change or interruption. | Cycle 1 and Cycle 2 at Day 15 pre-dose and at 2, 4, and 6 hours post-dose. Cycle=28 days |
| LEQ803 Plasma Concentrations | Blood samples were collected to assess the concentration by time point for LEQ803, a metabolite of ribociclib. Participants were classified into the following dose groups at each timepoint: 1) ribociclib 600 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 600 mg immediately prior to the blood collection without a dose change or interruption. 2) ribociclib 400 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 400 mg immediately prior to the blood collection without a dose change or interruption. 3) ribociclib 200 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 200 mg immediately prior to the blood collection without a dose change or interruption. | Cycle 1 and Cycle 2 at Day 15 pre-dose and at 2, 4, and 6 hours post-dose. Cycle = 28 days |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Highlands Oncology Group . | Fayetteville | Arkansas | 72703 | United States |
| UCLA Medical Center . | Los Angeles | California | 90095 | United States |
| Central Coast Medical Oncology Corporation SC | Santa Maria | California | 93454 | United States |
| St Joseph Heritage Healthcare | Santa Rosa | California | 94503 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80528 | United States |
| Florida Cancer Research Institute Dept of Oncology | Davie | Florida | 33328 | United States |
| Florida Hospital Cancer Institute SC | Orlando | Florida | 32804 | United States |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| John D Archbold Memorial Hospital Main | Thomasville | Georgia | 31792 | United States |
| Moanalua Medical Center. Attn: Oncology Dept SC | Honolulu | Hawaii | 96817 | United States |
| Oncology Specialists, SC Advocate Medical Group-Niles | Park Ridge | Illinois | 60068-0736 | United States |
| Jackson Oncology Associates SC | Jackson | Mississippi | 39202 | United States |
| Meridian Health Systems Regulatory | Neptune City | New Jersey | 07753 | United States |
| University of New Mexico Cancer Center SC | Albuquerque | New Mexico | 87131 | United States |
| CR Wood Cancer Center SC | Glens Falls | New York | 12801 | United States |
| Clinical Research Alliance . | Lake Success | New York | 11042 | United States |
| NYU Langone Med Center CV Research NYU Langone Medical Center | New York | New York | 10016 | United States |
| Genesis Cancer Services SC | Zanesville | Ohio | 43701 | United States |
| Penn State University Milton S Hershey Medical Center SC | Hershey | Pennsylvania | 17033 | United States |
| Millennium Research Clin Develop SC | Houston | Texas | 77090 | United States |
| Northern Utah Cancer Associates CFTY720DUS01 | Ogden | Utah | 84403-3105 | United States |
| Providence Regional Cancer Partnership . | Everett | Washington | 98201 | United States |
| Providence Regional Cancer System SC | Lacey | Washington | 98503 | United States |
| Virginia Mason Medical Center-Oncology SC | Seattle | Washington | 98101 | United States |
| Novartis Investigative Site | St Leonards | New South Wales | 2065 | Australia |
| Novartis Investigative Site | Herston | Queensland | 4029 | Australia |
| Novartis Investigative Site | East Melbourne | Victoria | 3002 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Innsbruck | Tyrol | 6020 | Austria |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Vienna | A-1100 | Austria |
| Novartis Investigative Site | Aalst | 9300 | Belgium |
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| Novartis Investigative Site | Brampton | Ontario | L6R 3J7 | Canada |
| Novartis Investigative Site | Kingston | Ontario | K7L 5P9 | Canada |
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| Novartis Investigative Site | Montreal | Quebec | H3G 1L5 | Canada |
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| Novartis Investigative Site | Strasbourg | Cedex | 67000 | France |
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| Novartis Investigative Site | Langen | Hesse | 63225 | Germany |
| Novartis Investigative Site | Georgsmarienhütte | Lower Saxony | 49124 | Germany |
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| Novartis Investigative Site | Ravensburg | 88214 | Germany |
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| Novartis Investigative Site | Tübingen | 72076 | Germany |
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| Novartis Investigative Site | Weiden | 92637 | Germany |
| Novartis Investigative Site | Budapest | 1134 | Hungary |
| Novartis Investigative Site | Budapest | H 1122 | Hungary |
| Novartis Investigative Site | Budapest | H-1032 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Szolnok | H-5000 | Hungary |
| Novartis Investigative Site | L’Aquila | AQ | 67100 | Italy |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Catania | CT | 95124 | Italy |
| Novartis Investigative Site | Lecce | LE | 73100 | Italy |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Pontedera | PI | 56025 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Amman | 11941 | Jordan |
| Novartis Investigative Site | Beirut | 1107 2020 | Lebanon |
| Novartis Investigative Site | El Achrafiyé | 166830 | Lebanon |
| Novartis Investigative Site | Johor Bahru | Johor | 81100 | Malaysia |
| Novartis Investigative Site | Kuching | Sarawak | 93586 | Malaysia |
| Novartis Investigative Site | Oaxaca City | 68000 | Mexico |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| Novartis Investigative Site | Breda | 4819 EV | Netherlands |
| Novartis Investigative Site | Deventer | 7416 SE | Netherlands |
| Novartis Investigative Site | Enschede | 7513 ER | Netherlands |
| Novartis Investigative Site | Groningen | 9728 NZ | Netherlands |
| Novartis Investigative Site | Hoofddorp | 2134 TM | Netherlands |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Nieuwegein | 3435 CM | Netherlands |
| Novartis Investigative Site | Roermond | 6043 CV | Netherlands |
| Novartis Investigative Site | Sittard-Geleen | 6162 BG | Netherlands |
| Novartis Investigative Site | The Hague | 2545 CH | Netherlands |
| Novartis Investigative Site | Tilburg | 5042 AD | Netherlands |
| Novartis Investigative Site | Oslo | NO 0424 | Norway |
| Novartis Investigative Site | Konin | 62 500 | Poland |
| Novartis Investigative Site | Warsaw | 04-125 | Poland |
| Novartis Investigative Site | Lisbon | 1400-038 | Portugal |
| Novartis Investigative Site | Porto | 4200-072 | Portugal |
| Novartis Investigative Site | Arkhangelsk | 163045 | Russia |
| Novartis Investigative Site | Tambov | 392000 | Russia |
| Novartis Investigative Site | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Granada | Andalusia | 18014 | Spain |
| Novartis Investigative Site | Madrid | Andalusia | 28046 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41014 | Spain |
| Novartis Investigative Site | Sant Joan Despí | Barcelona | 08970 | Spain |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15009 | Spain |
| Novartis Investigative Site | Alcorcón | Madrid | 28922 | Spain |
| Novartis Investigative Site | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Madrid | 28222 | Spain |
| Novartis Investigative Site | Eskilstuna | SE-631 88 | Sweden |
| Novartis Investigative Site | Sundsvall | 851 86 | Sweden |
| Novartis Investigative Site | Vaxjo | SE-351 85 | Sweden |
| Novartis Investigative Site | Aarau | 5000 | Switzerland |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Zurich | 8038 | Switzerland |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Istanbul | 34303 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34381 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34662 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35575 | Turkey (Türkiye) |
| Novartis Investigative Site | Plymouth | Devon | PL6 8DH | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| 37673211 | Derived | Andre F, Su F, Solovieff N, Hortobagyi G, Chia S, Neven P, Bardia A, Tripathy D, Lu YS, Lteif A, Taran T, Babbar N, Slamon D, Arteaga CL. Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials. Ann Oncol. 2023 Nov;34(11):1003-1014. doi: 10.1016/j.annonc.2023.08.011. Epub 2023 Sep 5. |
| 37653397 | Derived | Neven P, Fasching PA, Chia S, Jerusalem G, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Zarate JP, Wang Y, Chakravartty A, Wang C, Slamon DJ. Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant. Breast Cancer Res. 2023 Aug 31;25(1):103. doi: 10.1186/s13058-023-01701-9. |
| 36800111 | Derived | Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17. |
| 34158598 | Derived | Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22. |
| 34102253 | Derived | Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Valeria Bianchi G, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Ji Y, Wang C, Deore U, Chakravartty A, Zarate JP, Taran T, Fasching PA. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021 Aug;32(8):1015-1024. doi: 10.1016/j.annonc.2021.05.353. Epub 2021 Jun 5. |
| 33769862 | Derived | Prat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. |
| 31826360 | Derived | Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020 Feb 6;382(6):514-524. doi: 10.1056/NEJMoa1911149. Epub 2019 Dec 11. |
| 31305131 | Derived | Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15. |
| 29860922 | Derived | Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Vidam G, Wang Y, Rodriguez Lorenc K, Miller M, Taran T, Jerusalem G. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-2472. doi: 10.1200/JCO.2018.78.9909. Epub 2018 Jun 3. |
| FG001 |
| Placebo + Fulvestrant |
Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant. |
| Untreated |
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| Crossover Cohort | Participants in the placebo+fulvestrant arm who crossed over to the ribociclib+fulvestrant arm and received at least one dose of the study treatment. |
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| COMPLETED | Treatment ongoing at the time of the cut-off 11-Jan-2023 |
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| NOT COMPLETED |
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| Post-treatment Efficacy Follow-up |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ribociclib + Fulvestrant | Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. |
| BG001 | Placebo + Fulvestrant | Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) Per Investigator Assessment | PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. The distribution of PFS between the two arms was compared using a stratified log-rank test at a one-sided 2.5% level of significance. The PFS hazard ratio with two-sided 95% confidence interval was derived from the stratified Cox proportional hazards model. | The Full Analysis Set (FAS) including all randomized patients. | Posted | Median | 95% Confidence Interval | Months | From randomization to first documented progression or death, assessed up to approximately 26 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status. As per protocol, the final OS analysis was conducted after approximately 351 deaths were documented. OS was estimated using the Kaplan-Meier method. The median OS, along with 95% confidence intervals (CIs), was reported for each treatment group. The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to death, assessed up to approximately 46 months |
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| Secondary | Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC) | PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via BIRC assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to first documented progression or death, assessed up to approximately 26 months |
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| Secondary | Overall Response Rate (ORR) Per Investigator Assessment | ORR was defined as the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per investigator assessment. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | FAS including all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 26 months |
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| Secondary | Clinical Benefit Rate (CBR) Per Investigator Assessment | CBR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 as per investigator assessment. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | FAS including all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 26 months |
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| Secondary | Time to Response (TTR) Per Investigator Assessment | TTR was defined as the time from randomization to the first documented and confirmed response (CR or PR) as defined by RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate TTR, and the median TTR, along with 95% confidence intervals, was reported for each treatment group. Participants who did not achieve a confirmed response were censored at the maximum follow-up time for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | FAS including all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From randomization to first response, assessed up to approximately 26 months |
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| Secondary | Duration of Response (DOR) Per Investigator Assessment | DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Randomized participants with confirmed CR or PR as per investigator assessment | Posted | Median | 95% Confidence Interval | Months | From first documented response to progression or death, assessed up to approximately 26 months |
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| Secondary | Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) in One Score Category | ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 26 months |
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| Secondary | Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30) | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, a GHS/QoL scale, and 6 single items. GHS/QoL scale scores range between 0 and 100. A high score for GHS/QoL represents better functioning or QoL. The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation. | FAS including all randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to approximately 26 months |
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| Secondary | Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30 | The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, a GHS/QoL scale, and 6 single items. GHS/QoL scale scores range between 0 and 100. A high score for GHS/QoL represents better functioning or QoL. The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression. | Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, every 8 weeks after randomization during 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 months |
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| Secondary | Ribociclib Plasma Concentrations | Blood samples were collected to assess the concentration by time point for ribociclib. Participants were classified into the following dose groups at each timepoint: 1) ribociclib 600 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 600 mg immediately prior to the blood collection without a dose change or interruption. 2) ribociclib 400 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 400 mg immediately prior to the blood collection without a dose change or interruption. 3) ribociclib 200 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 200 mg immediately prior to the blood collection without a dose change or interruption. | All participants with at least one evaluable ribociclib concentration. Number analyzed indicated the number of participants with an evaluable ribociclib concentration at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram (ng) / miliLiter (mL) | Cycle 1 and Cycle 2 at Day 15 pre-dose and at 2, 4, and 6 hours post-dose. Cycle=28 days |
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| Secondary | LEQ803 Plasma Concentrations | Blood samples were collected to assess the concentration by time point for LEQ803, a metabolite of ribociclib. Participants were classified into the following dose groups at each timepoint: 1) ribociclib 600 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 600 mg immediately prior to the blood collection without a dose change or interruption. 2) ribociclib 400 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 400 mg immediately prior to the blood collection without a dose change or interruption. 3) ribociclib 200 mg: consisted of all participants who provided evaluable concentrations after receiving at least 10 consecutive daily ribociclib doses of 200 mg immediately prior to the blood collection without a dose change or interruption. | All participants with at least one evaluable ribociclib concentration. Number analyzed indicated the number of participants with an evaluable ribociclib concentration at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 and Cycle 2 at Day 15 pre-dose and at 2, 4, and 6 hours post-dose. Cycle = 28 days |
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| Post-Hoc | All Collected Deaths | Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment. Post-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study. Crossover post-treatment efficacy/survival follow-up deaths were collected from day 31 after last dose of crossover treatment to end of study. | FAS including all randomized participants | Posted | Count of Participants | Participants | Pre-treatment: Up to 28 days prior to treatment. On-treatment: Up to 82 months. Crossover on-treatment: Up to 3.5 months. Post-treatment efficacy/survival follow-up: Up to 82 months. Crossover post-treatment efficacy/survival follow-up: Up to 1 year |
|
On-treatment AEs: from 1st dose to 30 days post-treatment (or start of crossover treatment), up to 82 months. Post-treatment efficacy/survival follow-up deaths: from 31 days post-treatment to end of study, up to 82 months. Crossover on-treatment AEs: from 1st dose to 30 days post-crossover treatment, up to 3.5 months. Crossover post-treatment efficacy/survival follow-up deaths: from 31 days post-crossover treatment to end of study, up to 1 year
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ribociclib + Fulvestrant (On-treatment) | AEs during on-treatment period (up to 30 days after last dose of treatment) | 13 | 483 | 179 | 483 | 475 | 483 |
| EG001 | Ribociclib + Fulvestrant (Post-treatment Efficacy/Survival Follow-up) | Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period | 264 | 380 | 0 | 0 | 0 | 0 |
| EG002 | Placebo + Fulvestrant (On-treatment) | AEs during on-treatment period (up to 30 days after last dose of treatment or one day before first dose of crossover treatment for crossover participants) | 8 | 241 | 51 | 241 | 225 | 241 |
| EG003 | Placebo + Fulvestrant (Post-treatment Efficacy/Survival Follow-up) | Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period | 153 | 210 | 0 | 0 | 0 | 0 |
| EG004 | Crossover to Ribociclib + Fulvestrant (Crossover On-treatment) | AEs during crossover on-treatment period (from start of crossover treatment up to 30 days after last dose of crossover treatment) | 0 | 3 | 1 | 3 | 3 | 3 |
| EG005 | Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Efficacy/Survival Follow-up) | Deaths collected in the crossover post-treatment efficacy/survival follow-up period (starting from day 31 post-crossover treatment). No AEs were collected during this period | 1 | 1 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Aortic valve sclerosis | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Tachyarrhythmia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (25.1) | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA (25.1) | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA (25.1) | Systematic Assessment |
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| Myopia | Eye disorders | MedDRA (25.1) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Anal incontinence | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Gingival disorder | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Swelling face | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Terminal state | General disorders | MedDRA (25.1) | Systematic Assessment |
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| Acute hepatic failure | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Hepatic cytolysis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bladder hypertrophy | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vaginal haematoma | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2023 | Nov 2, 2023 | SAP_003.pdf |
| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589651 | ribociclib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Physician Decision |
|
| Progressive disease |
|
| Study Terminated as per protocol |
|
| Subject/Guardian Decision |
|
| Male |
|
| Asian |
|
| Native American |
|
| Black |
|
| Other |
|
| Unkown |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| OG001 |
| Placebo + Fulvestrant |
Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. |
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Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. |
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|
Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. |
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Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant. |
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