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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPCY | Other Identifier | Eli Lilly and Company | |
| 2020-000290-24 | EudraCT Number |
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The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 milligram (mg) Abemaciclib Twice Daily | Experimental | Participants received 200 mg abemaciclib administered orally twice daily on a continuous dosing schedule (28-day cycle) until symptomatic and/or radiographic progression, unacceptable toxicity, or until another discontinuation criterion is met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR]) | ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) in soft tissue per response evaluation criteria in solid tumors (RECIST) version 1.1 and do not have concurrent bone progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3), as assessed by the investigator. ORR = (participants with confirmed CR and no bone progression) + (participants with confirmed PR and no bone progression) x 100 / all treated participants. | From Date of First Dose until Objective Progression (Up To 12.8 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-Free Survival (rPFS) | The rPFS time is measured from the date of first dose to the earliest date of investigator-assessed radiographic progression per RECIST 1.1 for soft tissue and PCWG3 criteria for bone, or death from any cause, whichever occurred first. Participants who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment (if available) or date of first dose if no post initiation (i.e., postbaseline) radiographic assessment is available. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States | ||
| Seattle Cancer Care Alliance |
Not provided
| Label | URL |
|---|---|
| Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1) | View source |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 Milligram (mg) Abemaciclib Twice Daily | Participants received 200 mg abemaciclib administered orally twice daily on a continuous dosing schedule (28-day cycle) until symptomatic and/or radiographic progression, unacceptable toxicity, or until another discontinuation criterion is met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 4, 2021 | Apr 20, 2023 |
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| From Date of First Dose until Objective Progression or Death from Any Cause (Up To 12.8 Months) |
| Overall Survival (OS) | OS time is measured from the date of first dose to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. | From Date of First Dose until Date of Death from Any Cause (Up To 28 Months) |
| Duration of Response (DoR) | DoR is measured only for confirmed responders (participants with a confirmed soft tissue best overall response of CR or PR per RECIST 1.1 no concurrent bone progression per PCWG3). It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator-assessed radiographic progression or death from any cause, whichever is earlier. | CR or PR to Disease Progression or Death Due to Any Cause (Up to 12 Months) |
| Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) | The DCR is defined as the percentage of participants with confirmed soft tissue best overall response of CR, PR, or stable disease (SD) per RECIST 1.1, and do not have concurrent bone disease progression per PCWG3. | From Date of First Dose until Measured Progressive Disease or Death Due to Any Cause (Up To 12.8 Months) |
| Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression is defined as the time from the date of treatment initiation to the date of first observation of PSA progression. The PSA progression is defined as a greater than or equal to (>=) 25 percentage (%) increase and an absolute increase of >=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later. | From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months) |
| Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response (PSA Response Rate) | The PSA response rate is defined as the percentage of participants with a reduction in PSA level ≥50% from baseline, confirmed with a second assessment conducted at least 3 weeks later. | From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months) |
| Time to Symptomatic Progression | Time to symptomatic progression is defined as the time from first dose to any of the following (whichever occurred earlier): 1) symptomatic skeletal event, defined as symptomatic fracture, surgery, or radiation to bone, or spinal cord compression; 2) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anticancer therapy; and 3) development of clinically significant symptoms due to locoregional tumor progression requiring surgical intervention or radiation therapy. For participants who were not known to have symptomatic progression at the time of data analysis, data were censored on the last date at which no symptomatic progression was indicated. | From Date of First Dose until Symptomatic Progression (Up to 12.8 Months) |
| Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib | PK: Cmax,ss of abemaciclib is reported. The cycle length was 28 days. | Cycle (C) 1 Day (D) 1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
| PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib | PK: Cmin,ss of abemaciclib is reported. | C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
| PK: Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib Metabolites (Total Active Species) | PK: Cmax,ss of abemaciclib metabolites (Total Active Species) is reported. | C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
| PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib Metabolites (Total Active Species) | PK: Cmin,ss of abemaciclib metabolites (Total Active Species) is reported. | C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
| Percentage of Participants With Expression of Ki-67 Proliferation Marker by Immunohistochemistry (IHC) | Percentage of participants with expression of Ki-67 proliferation marker at baseline by immunohistochemistry. Baseline expression of the Ki-67 proliferation marker was evaluated by IHC utilizing a 20% or higher score to define high Ki-67 expression. The percentage of Ki-67 positive cells was defined by the number of non-apoptotic tumor cells with unequivocal brown nuclear staining (intensities ≥1 using a 0-3 scale) over the total number of non-apoptotic tumor cells. Unit of Measure is percentage of participants with low or high baseline Ki-67 expression. | Baseline |
| Seattle |
| Washington |
| 98109 |
| United States |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut Paoli-Calmettes | Marseille | 13273 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Institut Catala d'Oncologia | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Corporacion Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg Abemaciclib Twice Daily | Participants received 200 mg abemaciclib administered orally twice daily on a continuous dosing schedule (28-day cycle) until symptomatic and/or radiographic progression, unacceptable toxicity, or until another discontinuation criterion is 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 | Number | participants |
|
| 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 Confirmed Objective Response (Objective Response Rate [ORR]) | ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) in soft tissue per response evaluation criteria in solid tumors (RECIST) version 1.1 and do not have concurrent bone progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3), as assessed by the investigator. ORR = (participants with confirmed CR and no bone progression) + (participants with confirmed PR and no bone progression) x 100 / all treated participants. | All 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 Objective Progression (Up To 12.8 Months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Radiographic Progression-Free Survival (rPFS) | The rPFS time is measured from the date of first dose to the earliest date of investigator-assessed radiographic progression per RECIST 1.1 for soft tissue and PCWG3 criteria for bone, or death from any cause, whichever occurred first. Participants who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment (if available) or date of first dose if no post initiation (i.e., postbaseline) radiographic assessment is available. | All participants who received at least one dose of the study drug. Participants censored = 11. | Posted | Median | 95% Confidence Interval | months | From Date of First Dose until Objective Progression or Death from Any Cause (Up To 12.8 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS time is measured from the date of first dose to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. | All participants who received at least one dose of the study drug. Participants censored = 13. | Posted | Median | 95% Confidence Interval | months | From Date of First Dose until Date of Death from Any Cause (Up To 28 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | DoR is measured only for confirmed responders (participants with a confirmed soft tissue best overall response of CR or PR per RECIST 1.1 no concurrent bone progression per PCWG3). It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator-assessed radiographic progression or death from any cause, whichever is earlier. | All randomized participants who received at least one dose of the study drug and had CR or PR responses. The median was not achieved due to insufficient sample data. | Posted | Median | Full Range | months | CR or PR to Disease Progression or Death Due to Any Cause (Up to 12 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) | The DCR is defined as the percentage of participants with confirmed soft tissue best overall response of CR, PR, or stable disease (SD) per RECIST 1.1, and do not have concurrent bone disease progression per PCWG3. | All 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 Measured Progressive Disease or Death Due to Any Cause (Up To 12.8 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression is defined as the time from the date of treatment initiation to the date of first observation of PSA progression. The PSA progression is defined as a greater than or equal to (>=) 25 percentage (%) increase and an absolute increase of >=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later. | All participants who received at least one dose of the study drug. Participants censored = 31. | Posted | Median | 95% Confidence Interval | months | From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response (PSA Response Rate) | The PSA response rate is defined as the percentage of participants with a reduction in PSA level ≥50% from baseline, confirmed with a second assessment conducted at least 3 weeks later. | All participants who received at least one dose of the study drug. | Posted | Number | percentage of participants | From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Symptomatic Progression | Time to symptomatic progression is defined as the time from first dose to any of the following (whichever occurred earlier): 1) symptomatic skeletal event, defined as symptomatic fracture, surgery, or radiation to bone, or spinal cord compression; 2) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anticancer therapy; and 3) development of clinically significant symptoms due to locoregional tumor progression requiring surgical intervention or radiation therapy. For participants who were not known to have symptomatic progression at the time of data analysis, data were censored on the last date at which no symptomatic progression was indicated. | All participants who received at least one dose of the study drug. Participants censored = 28. | Posted | Median | 95% Confidence Interval | months | From Date of First Dose until Symptomatic Progression (Up to 12.8 Months) |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib | PK: Cmax,ss of abemaciclib is reported. The cycle length was 28 days. | All participants who received at least one dose of study drug had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/ mL) | Cycle (C) 1 Day (D) 1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
|
| ||||||||||||||||||||||||||
| Secondary | PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib | PK: Cmin,ss of abemaciclib is reported. | All participants who received at least one dose of study drug had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
|
| ||||||||||||||||||||||||||
| Secondary | PK: Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib Metabolites (Total Active Species) | PK: Cmax,ss of abemaciclib metabolites (Total Active Species) is reported. | All participants who received at least one dose of study drug had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micromolar per liter (µmol/L) | C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
|
| ||||||||||||||||||||||||||
| Secondary | PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib Metabolites (Total Active Species) | PK: Cmin,ss of abemaciclib metabolites (Total Active Species) is reported. | All participants who received at least one dose of study drug had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol/L | C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Expression of Ki-67 Proliferation Marker by Immunohistochemistry (IHC) | Percentage of participants with expression of Ki-67 proliferation marker at baseline by immunohistochemistry. Baseline expression of the Ki-67 proliferation marker was evaluated by IHC utilizing a 20% or higher score to define high Ki-67 expression. The percentage of Ki-67 positive cells was defined by the number of non-apoptotic tumor cells with unequivocal brown nuclear staining (intensities ≥1 using a 0-3 scale) over the total number of non-apoptotic tumor cells. Unit of Measure is percentage of participants with low or high baseline Ki-67 expression. | All participants with evaluable tumor tissue specimens | Posted | Number | Percentage of participants | Baseline |
|
|
Baseline Up to 28 Months
All participants who received at least one dose of the 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 | 200 mg Abemaciclib Twice Daily | Participants received 200 mg abemaciclib administered orally twice daily on a continuous dosing schedule (28-day cycle) until symptomatic and/or radiographic progression, unacceptable toxicity, or until another discontinuation criterion is met. | 31 | 44 | 18 | 44 | 42 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2020 | Apr 20, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000590451 | abemaciclib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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