Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-JCAO | Other Identifier | Eli Lilly and Company |
Not provided
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Not provided
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The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 500 milligrams (mg), oral, daily, up to six 28-day cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Progression (FFP) for at Least 3 Cycles | Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. The percentage of FFP was computed as the number of participants documented to be progression free after 3 cycles of treatment divided by the number of treated participants and then multiplied by 100. | Baseline through at least 3 cycles of treatment (28-day cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate) | Baseline to 22.01 months | |
| Progression-Free Survival (PFS) | PFS time was defined as the time from the date of enrollment to the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. Progression-free survival time was censored at the date of the last assessment visit for participants who were still alive and who had not had documented progressive disease. |
Not provided
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 to 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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Woolloongabba | Queensland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9366889 | Background | Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108. doi: 10.1097/00005650-199711000-00002. |
Not provided
Not provided
Participant flow reports those participants who discontinued from study drug. Only participants without confirmed progressive disease at the 30-day post-therapy visit were assessed for progression by radiological method every 3 months until disease progression.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin | 500 milligrams (mg) oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin | 500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Freedom From Progression (FFP) for at Least 3 Cycles | Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. The percentage of FFP was computed as the number of participants documented to be progression free after 3 cycles of treatment divided by the number of treated participants and then multiplied by 100. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through at least 3 cycles of treatment (28-day cycle) |
|
From randomization through 21 cycles (28-day cycle) and 30-day follow-up
Not provided
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 | Enzastaurin | 500 mg oral dose administered once daily, in the morning, during each 28-day cycle of therapy for planned duration of treatment up to 6 cycles in the absence of disease progression or for any other cause of discontinuation. Treatment was continued until unacceptable toxicity or progressive disease occurred. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
Not provided
Not provided
Not provided
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| Baseline to measured progressive disease or death due to any cause up to 22.01 months |
| Overall Survival (OS) | OS was defined as the time from the date of enrollment to the date of death due to any cause. For each participant who was not known to have died as of the data-inclusion cut-off date, OS was censored for that analysis at the date of the last assessment visit prior to the cut-off date. | Baseline to date of death from any cause at least up to 23.10 months |
| Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response] | Duration of overall response for responders was measured from the date that measurement criteria were met for CR, CRu, PR or SD (whichever status occurred first) until the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas Guidelines, CR was defined as the disappearance of all lesions. CRu was the disappearance of clinical and radiographic evidence of disease, normal appearance of spleen and greater than 75% regression in lymph node mass. PR was defined as at least a 50% decrease in the six largest dominant nodes. SD was when the response was poorer than partial response with no new lesions consistent with progressive disease. Duration of response was censored at the date of the last assessment visit for responders who were still alive and had not had documented progressive disease. | Date of progression or death due to any cause up to 22.01 months |
| Time to New Treatment | Time to new treatment was as the time from enrollment to the date new treatment for the cancer under study was initiated. Time to new treatment was censored at the date of the last assessment visit for participants who were not documented to have initiated a new treatment. | Baseline to date of new treatment up to 23.10 months |
| Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4) | The B symptoms, tumor-related symptoms, participant functioning, and health-related quality of life were assessed with FACT-Lym v. 4. FACT-Lym v. 4 consists of 42 items with 5-point rating scales for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The lymphoma tumor - specific subscale consists of 15 items with a score ranging from 0-60. Fact-Lymphoma total score ranges from 0-168. A higher score represents better quality of life. | Baseline, Cycles 2, 4 and 6 (28-day cycle) |
| Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status) | Overall health status and participant utility values were measured with the EuroQol-5D questionnaire. EuroQol-5D describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is divided into 3 levels: 1 (no problem), 2 (some problem), and 3 (extreme problem). The questionnaire records the level of problems on each of 5 dimensions and is converted into the EuroQol-5D index based on preference weights (Dolan 1997), where a score of 0.0 = death and 1.0 = perfect health. | Baseline, Cycles 2, 4 and 6 |
| Number of Participants With Protein Kinase C Beta (PKCβ) Expression by Immunohistochemistry (IHC) Staining | IHC staining of tumor samples was carried out to determine PKCβ expression. Staining intensity was measured on a semiquantitative scale of 0 (or negative) to 3 (high intensity). The final score combined the components of staining intensity and the percentage of positive cells and was defined as [1 * (percentage of cells staining at 1)] + [2 * (percentage of cells staining at 2)] + [3 * (percentage of cells staining at 3)]. Score ≥100 and staining intensity ≥2 indicates high expression for PKCβ, while score <100 and staining intensity ≤1 indicates low expression for PKCβ. | Baseline |
| Number of Participants With High Ki-67 Expression by IHC Staining | IHC staining of tumor samples was carried out to determine Ki-67 expression. High expression is defined as the percentage of positive cells ≥40%. | Baseline |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin) | Data presented are the number of participants who experienced SAEs, AEs, deaths due to progressive disease (PD), and deaths due to AEs while on treatment and death during the 30-day post-treatment follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Each cycle (28-day cycle) up to 21 cycles and 30-day follow-up |
| Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes) | The Steady-state plasma concentrations of total analytes (enzastaurin plus its active metabolite, LSN326020) observed after once-daily dosing were evaluated using sparse sampling methodology. | Cycles 1 [1-4 hours (h) and 4-8 h postdose], 2 (predose, 2-4 h and 6-8 h postdose), and 3 (predose and 2-8 h postdose) of Day 1 of each 28-day cycle |
| Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Parkville | Victoria | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Prahran | Victoria | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Wodonga | Victoria | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | East Melbourne | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Créteil | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Lille | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Nantes | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Rouen | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Tours | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Berlin | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Cologne | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Homburg Saar | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Kassel | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Groningen | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Nijmegen | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Rotterdam | Netherlands |
| Death Due to Study Disease |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline B Symptoms | B symptoms include weight loss >10% of body weight in the preceding 6 months, unexplained fevers >38°C, drenching night sweats and assigned an international prognostic index score of low (0-1), medium (2-3) or high (4-5). Higher scores indicate worse symptoms. | Count of Participants | Participants | No |
|
| Participants with High Lactate Dehydrogenase (LDH) | Participants with LDH >300 international units/liter (IU/L) are considered having high LDH. | Count of Participants | Participants | No |
|
|
|
| Secondary | Percentage of Participants With Complete Response (CR) Plus Unconfirmed Complete Response (CRu) Plus Partial Response (PR) (Objective Response Rate) | Zero participants were analyzed as no participant achieved CR, CRu or PR. | Posted | Baseline to 22.01 months |
|
|
| Secondary | Progression-Free Survival (PFS) | PFS time was defined as the time from the date of enrollment to the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas, participants were considered to have progressive disease if there was a 50% increase in the sum of the products of the greatest diameters (SPD) of the dominant nodal and non-nodal sites or appearance of new-involved site or lesion. Progression-free survival time was censored at the date of the last assessment visit for participants who were still alive and who had not had documented progressive disease. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug. Participants censored = 3. | Posted | Median | 95% Confidence Interval | months | Baseline to measured progressive disease or death due to any cause up to 22.01 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of enrollment to the date of death due to any cause. For each participant who was not known to have died as of the data-inclusion cut-off date, OS was censored for that analysis at the date of the last assessment visit prior to the cut-off date. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug. Participants censored = 39. | Posted | Median | 95% Confidence Interval | months | Baseline to date of death from any cause at least up to 23.10 months |
|
|
|
| Secondary | Duration of CR, CRu, PR or Stable Disease (SD) [Duration of Overall Response] | Duration of overall response for responders was measured from the date that measurement criteria were met for CR, CRu, PR or SD (whichever status occurred first) until the first date of documented progressive disease or death due to any cause, whichever occurred first. Using the Standardized Response Criteria for non-Hodgkin's lymphomas Guidelines, CR was defined as the disappearance of all lesions. CRu was the disappearance of clinical and radiographic evidence of disease, normal appearance of spleen and greater than 75% regression in lymph node mass. PR was defined as at least a 50% decrease in the six largest dominant nodes. SD was when the response was poorer than partial response with no new lesions consistent with progressive disease. Duration of response was censored at the date of the last assessment visit for responders who were still alive and had not had documented progressive disease. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and met criteria for CR, CRu, PR or SD. Participants censored = 2. | Posted | Median | 95% Confidence Interval | months | Date of progression or death due to any cause up to 22.01 months |
|
|
|
| Secondary | Time to New Treatment | Time to new treatment was as the time from enrollment to the date new treatment for the cancer under study was initiated. Time to new treatment was censored at the date of the last assessment visit for participants who were not documented to have initiated a new treatment. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug. Participants censored =16. | Posted | Median | 95% Confidence Interval | months | Baseline to date of new treatment up to 23.10 months |
|
|
|
| Secondary | Change in Scores From Baseline to Cycle 6 in Functional Assessment of Cancer Therapy Lymphoma Version 4 ( FACT-Lym v.4) | The B symptoms, tumor-related symptoms, participant functioning, and health-related quality of life were assessed with FACT-Lym v. 4. FACT-Lym v. 4 consists of 42 items with 5-point rating scales for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The lymphoma tumor - specific subscale consists of 15 items with a score ranging from 0-60. Fact-Lymphoma total score ranges from 0-168. A higher score represents better quality of life. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and had FACT-Lym assessed at baseline and Cycles 2, 4 and 6. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycles 2, 4 and 6 (28-day cycle) |
|
|
|
| Secondary | Change From Baseline to Cycle 6 in European Quality of Life-5D (EuroQol-5D) Index Score (Overall Health Status) | Overall health status and participant utility values were measured with the EuroQol-5D questionnaire. EuroQol-5D describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is divided into 3 levels: 1 (no problem), 2 (some problem), and 3 (extreme problem). The questionnaire records the level of problems on each of 5 dimensions and is converted into the EuroQol-5D index based on preference weights (Dolan 1997), where a score of 0.0 = death and 1.0 = perfect health. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and had EuroQol-5D assessed at baseline and Cycles 2, 4, and 6. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycles 2, 4 and 6 |
|
|
|
| Secondary | Number of Participants With Protein Kinase C Beta (PKCβ) Expression by Immunohistochemistry (IHC) Staining | IHC staining of tumor samples was carried out to determine PKCβ expression. Staining intensity was measured on a semiquantitative scale of 0 (or negative) to 3 (high intensity). The final score combined the components of staining intensity and the percentage of positive cells and was defined as [1 * (percentage of cells staining at 1)] + [2 * (percentage of cells staining at 2)] + [3 * (percentage of cells staining at 3)]. Score ≥100 and staining intensity ≥2 indicates high expression for PKCβ, while score <100 and staining intensity ≤1 indicates low expression for PKCβ. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and provided tissue specimens from the initial diagnosis for PKCβ expression analysis. | Posted | Count of Participants | Participants | No | Baseline |
|
|
|
| Secondary | Number of Participants With High Ki-67 Expression by IHC Staining | IHC staining of tumor samples was carried out to determine Ki-67 expression. High expression is defined as the percentage of positive cells ≥40%. | All enrolled participants with relapsed mantle cell lymphoma who received at least 1 dose of study drug and provided tissue specimens from the initial diagnosis for Ki-67 expression analysis. | Posted | Count of Participants | Participants | No | Baseline |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) (Safety of Enzastaurin) | Data presented are the number of participants who experienced SAEs, AEs, deaths due to progressive disease (PD), and deaths due to AEs while on treatment and death during the 30-day post-treatment follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Each cycle (28-day cycle) up to 21 cycles and 30-day follow-up |
|
|
|
| Secondary | Average Steady-State Plasma Concentration (Cav,ss,) of Enzastaurin and Total Analytes (Pharmacokinetics of Enzastaurin and Total Analytes) | The Steady-state plasma concentrations of total analytes (enzastaurin plus its active metabolite, LSN326020) observed after once-daily dosing were evaluated using sparse sampling methodology. | All enrolled participants who received at least 1 dose of study drug and had evaluable data for Cav,ss. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomoles/liter (nmol/L) | Cycles 1 [1-4 hours (h) and 4-8 h postdose], 2 (predose, 2-4 h and 6-8 h postdose), and 3 (predose and 2-8 h postdose) of Day 1 of each 28-day cycle |
|
|
|
| 20 |
| 60 |
| 54 |
| 60 |
| Febrile neutropenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | 16.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | 16.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | 16.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | 16.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | 16.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | 16.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | 16.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | 16.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Pharyngeal lesion | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 16.0 | Systematic Assessment |
|
| Haemoglobin | Investigations | 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | 16.0 | Systematic Assessment |
|
| Vulvovaginal burning sensation | Reproductive system and breast disorders | 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 16.0 | Systematic Assessment |
|
Not provided
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| Physical Well-being- Cycle 4 |
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| Physical Well-being- Cycle 6 |
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| Social Family Well-being- Baseline |
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| Social Family Well-being- Cycle 2 |
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| Social Family Well-being- Cycle 4 |
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| Social Family Well-being- Cycle 6 |
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| Emotional Well-being- Baseline |
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| Emotional Well-being- Cycle 2 |
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| Emotional Well-being- Cycle 4 |
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| Emotional Well-being- Cycle 6 |
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| Functional Well-being- Baseline |
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| Functional Well-being- Cycle 2 |
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| Functional Well-being- Cycle 4 |
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| Functional Well-being- Cycle 6 |
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| Lymphoma Subscale- Baseline |
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| Lymphoma Subscale- Cycle 2 |
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| Lymphoma Subscale- Cycle 4 |
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| Lymphoma Subscale- Cycle 6 |
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| Fact-Lymphoma Total Score- Baseline |
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| Fact-Lymphoma Total Score- Cycle 2 |
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| Fact-Lymphoma Total Score- Cycle 4 |
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| Fact-Lymphoma Total Score- Cycle 6 |
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| Cycle 4 |
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| Cycle 6 |
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| Title | Measurements |
|---|---|
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| Deaths due to AEs |
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| Deaths during 30-day follow-up |
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