Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPBN | Other Identifier | Eli Lilly and Company | |
| 2013-005548-27 | Other Identifier | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib | Experimental | 200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. | From Date of First Dose until Death Due to Any Cause (Up To 27 Months) |
Not provided
Inclusion Criteria.
Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
Prior treatment with at least 2 chemotherapy regimens:
Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
Have discontinued all previous therapies for cancer.
Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Arizona Hematology & Oncology Associates | Sedona | Arizona | 86336 | United States | ||
| HOPE Hematology Oncology Physicians and Extenders |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28533223 | Result | Dickler MN, Tolaney SM, Rugo HS, Cortes J, Dieras V, Patt D, Wildiers H, Hudis CA, O'Shaughnessy J, Zamora E, Yardley DA, Frenzel M, Koustenis A, Baselga J. MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR+/HER2- Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 1;23(17):5218-5224. doi: 10.1158/1078-0432.CCR-17-0754. Epub 2017 May 22. |
Not provided
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib | 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration of Response (DOR) | DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
| Progression Free Survival (PFS) | PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months) |
| Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR]) | Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
| Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) | Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
| Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | Cycle 6 Day 1 |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 | Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20 | Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose |
| Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score | EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. | Cycle 6 Day 1 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | United States |
| Univ of California San Francisco | San Francisco | California | 94115 | United States |
| Sansum Medical Research Foundation | Santa Barbara | California | 93105 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80220 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Advanced Medical Specialties | Miami | Florida | 33176 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Minnesota Oncology/Hematology PA | Minneapolis | Minnesota | 55404 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Sarah Cannon Research Institute SCRI | Nashville | Tennessee | 37203 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology - Bedford | Bedford | Texas | 76022 | United States |
| Presbyterian Hospital Dallas | Dallas | Texas | 75231 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Texas Oncology-Memorial City | Houston | Texas | 77024 | United States |
| Texas Oncology-Plano West | Plano | Texas | 75093 | United States |
| Texas Oncology-Sherman | Sherman | Texas | 75090-0504 | United States |
| US Oncology | The Woodlands | Texas | 77380 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Northwest Cancer Specialists PC | Vancouver | Washington | 98684 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brussels | 1000 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Charleroi | 6000 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leuven | 3000 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liège | 4000 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dijon | 21034 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Paris | 75248 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | 08035 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | 28007 | Spain |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | 46015 | Spain |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib | 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. | All enrolled participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. | All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=70. | Posted | Median | 95% Confidence Interval | Months | From Date of First Dose until Death Due to Any Cause (Up To 27 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. | All enrolled participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. | All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=35. | Posted | Median | 95% Confidence Interval | Months | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR]) | Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. | All enrolled participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) | Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100. | All enrolled participants who received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). | All randomized participants with a baseline and at least 1 post-baseline mBPI-sf data. | Posted | Count of Participants | Participants | No | Cycle 6 Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 | Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20 | All enrolled participants who received at least one dose of study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour/milliliters (ng*h/mL)] | Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score | EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. | All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data. | Posted | Count of Participants | Participants | No | Cycle 6 Day 1 |
|
|
Up To 45.57 Months
All enrolled participants who received at least one dose of study drug.
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 | Abemaciclib | 200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met. | 33 | 132 | 132 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Haematotoxicity | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pancreatic enzyme abnormality | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Renal function test abnormal | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000590451 | abemaciclib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| France |
|
| Spain |
|
|
|
|
|
|
| Participants |
|
|
|
|
|