Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPBB | Other Identifier | Eli Lilly and Company | |
| 2012-003614-14 | EudraCT Number |
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The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib | Experimental | 200 milligram (mg) abemaciclib administered orally every 12 hours on days 1 through 28 of a 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Disease Control Rate (DCR) Which Includes Complete Response (CR), Complete Response Unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD) | The DCR was estimated based on the Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). DCR was assessed from date of first dose until disease progression or death or start of new anticancer therapy. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms based on CT scan or bone marrow biopsy; CRu = the CR criteria is met and a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product diameter (SPD). PR is >= 50% decrease in SPD of the six largest nodal masses/no new sites of disease. Progressive Disease (PD) is defined as an increase by 25% in longest diameter, new lesion or assessable disease progression. SD=small changes not meeting the above criteria; DCR and its exact 95% confidence interval (CI) was estimated for treated participants using the Clopper-Pearson method. | From Date of First Dose until Disease Progression or Death or Start of New Anticancer Therapy (Up to 28 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Best Overall Disease Response (BOR) That Includes CR, CRu or PR | BOR was assessed based on the Response Criteria for Non-Hodgkin's Lymphomas and was measured from date of first dose until the earliest evidence of objective progression or start of new anticancer therapy. Any responses observed after objective progression or after the start of new anticancer therapy are excluded from the determination of best response. A second confirmatory radiological tumor assessment was performed at least 28 days after the first evidence of response (CR, CRu, or PR). Two objective status determinations of CR (or CRu) before progression were required for a best response of CR (or CRu). Two determinations of PR or better before progression, but not qualifying for CR or CRu, were required for a best response of PR. |
Not provided
Inclusion Criteria:
Have a diagnosis of relapsed or refractory Mantle Cell Lymphoma (MCL) according to the World Health Organization (WHO) classification that has relapsed after, or been refractory to, available standard treatments. However, participants who are intolerant of, or unable to receive a standard treatment are not required to have MCL that has relapsed after, or been refractory to, that specific standard treatment. Pathology must be reviewed and confirmed at the investigational site where participant is entered prior to enrollment
Have disease that is assessable according to the Response Criteria for Non- Hodgkin's Lymphomas
Have given written informed consent prior to any study-specific procedures
Have adequate organ function including:
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia
Are willing to make themselves available for the duration of the study and to follow study procedures
Are amenable to compliance with protocol schedules and testing
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Females with child-bearing potential must have a negative serum pregnancy test within 14 days of the first dose of study drug
Have a life expectancy of ≥12 weeks
Are able to swallow capsules
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 |
|---|---|---|---|---|---|---|
| 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. | Lille | 59037 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24919854 | Derived | Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13. |
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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.
Completers are those who died, or are alive and being followed at the end of the trial but off treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib | 200 milligram (mg) of Abemaciclib was administered orally every 12 hours on days 1 through 28 of a 28-day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib | 200 mg Abemaciclib was administered orally every 12 hours on days 1 through 28 of a 28-day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Who Achieve Disease Control Rate (DCR) Which Includes Complete Response (CR), Complete Response Unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD) | The DCR was estimated based on the Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). DCR was assessed from date of first dose until disease progression or death or start of new anticancer therapy. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms based on CT scan or bone marrow biopsy; CRu = the CR criteria is met and a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product diameter (SPD). PR is >= 50% decrease in SPD of the six largest nodal masses/no new sites of disease. Progressive Disease (PD) is defined as an increase by 25% in longest diameter, new lesion or assessable disease progression. SD=small changes not meeting the above criteria; DCR and its exact 95% confidence interval (CI) was estimated for treated participants using the Clopper-Pearson method. | All participants who received at least one dose of study drug and had evaluable DCR data. | Posted | Number | 95% Confidence Interval | percentage of participants | From Date of First Dose until Disease Progression or Death or Start of New Anticancer Therapy (Up to 28 Months) |
Baseline till end of follow-up (Up to 7.9 years)
All 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 milligram (mg) Abemaciclib administered orally every 12 hours on days 1 through 28 of a 28-day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
Not provided
Not provided
Not provided
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| From Date of First Dose until Disease Progression (Up to 28 Months) |
| Duration of Objective Response (DOR) | DOR is from the date when criteria for objective response (ie, CR, CRu or PR) are met, to the first documentation of relapse or disease progression or death due to any cause. DOR is based on the Response Criteria for Non-Hodgkin's Lymphomas of the Cancer and Leukemia Group B. CR is defined as disappearance of all disease, no symptoms and must last 4 weeks or "unconfirmed CR, (CRu)". PR is defined as >= 50% decrease in sum of product diameter (SPD), no increase or new lesion, or assessable disease stable or decreased, must last 4 weeks or CRu. Progressive Disease or PD is defined as an increase by 25% in longest diameter, new lesion, or assessable disease progression. DOR was analyzed using Kaplan-Meier methods. If the participant receives other anticancer therapy prior to progression, the participant was censored at the start date of this other therapy. | From Date of CR, CRu or PR until Disease Progression or Death Due to Any Cause (Up to 28 Months) |
| Progression-Free Survival (PFS) | PFS is defined as the date of first dose until disease progression or death due to any cause based on the Response Criteria for Non-Hodgkin's Lymphomas. Disease progression is defined as the first date of documentation of a new lesion or enlargement of a previous lesion, or the date after radiologic assessment has been completed. PD is defined as an increase by 25% in longest diameter, new lesion, or assessable disease progression. Progression-free survival was analyzed using Kaplan-Meier methods. If the participant receives other anticancer therapy prior to progression, the participant was censored at the start date of this other therapy. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up to 28 Months) |
| Overall Survival (OS) | OS is defined as from the date of first dose until 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 were censored on the last date the participant is known to be alive. Overall survival was analyzed using Kaplan-Meier methods. | From Date of First Dose until Death Due to Any Cause (Up to 28 Months) |
| Event-Free Survival | Event-free survival (time to treatment failure) is measured from date of first dose to disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, participant preference, initiation of new treatment without documented progression, or death due to any cause). 2 participants were censored. Event-free survival is defined only for responders (participants with a CR, CRu, or PR). | From Date of First Dose until Disease Progression, Discontinuation of Treatment, or Death Due to Any Cause (Up to 28 Months) |
| Time to Disease Progression | Time to Disease Progression is based on the response criteria of Non-Hodgkin's Lymphomas. Time to progression (TTP) is defined as the time from date of first dose until documented disease progression or death as a result of lymphoma. In TTP, deaths from other causes are censored either at the time of death or at an earlier time of assessment. | From Date of First Dose Until Disease Progression (Up to 28 Months) |
| Disease-Free Survival | Disease-free survival is measured from first dose until date of disease progression or the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment. Progressive Disease (PD) is defined as an increase by 25%, new lesion, or accessible progressive disease. Disease-Free Survival was assessed based on the response criteria of Non-Hodgkins Lymphomas. Disease-free survival is only defined for participants with response. | First Dose Until Date of Disease Progression or Time of Occurrence Disease-Free State or CR to Disease Recurrence or Death (Up to 28 Months) |
| Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) TOI and Subscale Scores | Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population). The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes and lower scores indicate worse outcomes. A positive change from baseline indicates an improvement and a negative change is a detriment. | Baseline, Cycle 5 (Up To Day 140) |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib | Predose, 1 hour (hr), 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
| PK - Area Under the Concentration-Time Curve From Zero to Last Time Point (AUC[0-tlast]) of Abemaciclib | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
| PK - Terminal Half Life (T 1/2) of Abemaciclib | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
| PK: Volume of Distribution (Vd) of Abemaciclib | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
| PK: Clearance (CL) of Abemaciclib | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
| 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. | Pessac | 33604 | 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. | Homburg | 66421 | Germany |
| 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. | Kassel | 34125 | Germany |
| 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. | Mainz | 55131 | Germany |
| 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. | Nuremberg | 90419 | Germany |
| 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. | Ulm | 89081 | Germany |
| 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 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieve Best Overall Disease Response (BOR) That Includes CR, CRu or PR | BOR was assessed based on the Response Criteria for Non-Hodgkin's Lymphomas and was measured from date of first dose until the earliest evidence of objective progression or start of new anticancer therapy. Any responses observed after objective progression or after the start of new anticancer therapy are excluded from the determination of best response. A second confirmatory radiological tumor assessment was performed at least 28 days after the first evidence of response (CR, CRu, or PR). Two objective status determinations of CR (or CRu) before progression were required for a best response of CR (or CRu). Two determinations of PR or better before progression, but not qualifying for CR or CRu, were required for a best response of PR. | All participants who received at least one dose of study drug and had evaluable BOR data. | Posted | Number | 95% Confidence Interval | percentage of participants | From Date of First Dose until Disease Progression (Up to 28 Months) |
|
|
|
| Secondary | Duration of Objective Response (DOR) | DOR is from the date when criteria for objective response (ie, CR, CRu or PR) are met, to the first documentation of relapse or disease progression or death due to any cause. DOR is based on the Response Criteria for Non-Hodgkin's Lymphomas of the Cancer and Leukemia Group B. CR is defined as disappearance of all disease, no symptoms and must last 4 weeks or "unconfirmed CR, (CRu)". PR is defined as >= 50% decrease in sum of product diameter (SPD), no increase or new lesion, or assessable disease stable or decreased, must last 4 weeks or CRu. Progressive Disease or PD is defined as an increase by 25% in longest diameter, new lesion, or assessable disease progression. DOR was analyzed using Kaplan-Meier methods. If the participant receives other anticancer therapy prior to progression, the participant was censored at the start date of this other therapy. | All participants who received at least one dose of study drug and achieved BOR. 4 participants were censored. | Posted | Median | 95% Confidence Interval | months | From Date of CR, CRu or PR until Disease Progression or Death Due to Any Cause (Up to 28 Months) |
|
|
|
| Secondary | Progression-Free Survival (PFS) | PFS is defined as the date of first dose until disease progression or death due to any cause based on the Response Criteria for Non-Hodgkin's Lymphomas. Disease progression is defined as the first date of documentation of a new lesion or enlargement of a previous lesion, or the date after radiologic assessment has been completed. PD is defined as an increase by 25% in longest diameter, new lesion, or assessable disease progression. Progression-free survival was analyzed using Kaplan-Meier methods. If the participant receives other anticancer therapy prior to progression, the participant was censored at the start date of this other therapy. | All participants who received at least one dose of study drug. 9 participants were censored. | Posted | Median | 95% Confidence Interval | Months | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up to 28 Months) |
|
|
|
| Secondary | Overall Survival (OS) | OS is defined as from the date of first dose until 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 were censored on the last date the participant is known to be alive. Overall survival was analyzed using Kaplan-Meier methods. | All participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From Date of First Dose until Death Due to Any Cause (Up to 28 Months) |
|
|
|
| Secondary | Event-Free Survival | Event-free survival (time to treatment failure) is measured from date of first dose to disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, participant preference, initiation of new treatment without documented progression, or death due to any cause). 2 participants were censored. Event-free survival is defined only for responders (participants with a CR, CRu, or PR). | All participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | From Date of First Dose until Disease Progression, Discontinuation of Treatment, or Death Due to Any Cause (Up to 28 Months) |
|
|
|
| Secondary | Time to Disease Progression | Time to Disease Progression is based on the response criteria of Non-Hodgkin's Lymphomas. Time to progression (TTP) is defined as the time from date of first dose until documented disease progression or death as a result of lymphoma. In TTP, deaths from other causes are censored either at the time of death or at an earlier time of assessment. | All participants who received at least one dose of study drug. 17 participants were censored. | Posted | Median | 95% Confidence Interval | Months | From Date of First Dose Until Disease Progression (Up to 28 Months) |
|
|
|
| Secondary | Disease-Free Survival | Disease-free survival is measured from first dose until date of disease progression or the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment. Progressive Disease (PD) is defined as an increase by 25%, new lesion, or accessible progressive disease. Disease-Free Survival was assessed based on the response criteria of Non-Hodgkins Lymphomas. Disease-free survival is only defined for participants with response. | All participants who received at least one dose of study drug. 5 participants were censored. | Posted | Median | 95% Confidence Interval | Months | First Dose Until Date of Disease Progression or Time of Occurrence Disease-Free State or CR to Disease Recurrence or Death (Up to 28 Months) |
|
|
|
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) TOI and Subscale Scores | Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population). The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes and lower scores indicate worse outcomes. A positive change from baseline indicates an improvement and a negative change is a detriment. | All participants who received at least one dose of study drug and had baseline and post baseline FACT-Lym data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycle 5 (Up To Day 140) |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/ml) | Predose, 1 hour (hr), 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
|
|
|
| Secondary | PK - Area Under the Concentration-Time Curve From Zero to Last Time Point (AUC[0-tlast]) of Abemaciclib | All randomized who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram/milliliter (hr*ng/ml) | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
|
|
|
| Secondary | PK - Terminal Half Life (T 1/2) of Abemaciclib | Zero participants were analyzed due to the calculation of half-life (t1/2) by noncompartmental analysis was not possible due to cessation of sampling at 8 hours postdose. | Posted | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
|
|
| Secondary | PK: Volume of Distribution (Vd) of Abemaciclib | Zero participants were analyzed. Vd was not calculated by non-compartmental analysis with the available data. | Posted | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
|
|
| Secondary | PK: Clearance (CL) of Abemaciclib | Zero participants were analyzed. CL was not calculated due to PK sampling schedule was not suitable for estimation of these PK parameters. | Posted | Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose |
|
|
| 23 |
| 28 |
| 13 |
| 28 |
| 28 |
| 28 |
| Ileus | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Leukopenia | 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 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | 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 |
|
| 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 |
|
| Conjunctivitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Presyncope | Nervous system 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 |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| FACT-Lym TOI Score |
|