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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-JCBJ | Other Identifier | Eli Lilly and Company | |
| PRELUDE | Other Identifier | Eli Lilly and Company |
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This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.
This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Disease-Free Survival | Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy. | Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival at 2 Years | Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method. | Baseline to 2 Years |
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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 |
|---|---|---|---|---|---|---|
| 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. | Anchorage | Alaska | 99508 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27217449 | Derived | Crump M, Leppa S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. doi: 10.1200/JCO.2015.65.7171. Epub 2016 May 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin: Arm A - Experimental | Enzastaurin 500 milligram (mg) administered orally (PO) each day (QD) after an initial loading dose of 1125 mg on Day 1. |
| FG001 | Placebo: Arm B - Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | oral, daily |
|
| Event-Free Survival |
Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy. |
| Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months) |
| Event-Free Survival at 2 Years | Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method. | Baseline to 2 Years |
| Overall Survival | Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause. | Baseline to Date of Death from Any Cause (up to 80.30 months) |
| Number of Participants With Treatment-Emergent Adverse Events | Number of participants with treatment-emergent adverse events. | First dose through 30 days post-study treatment discontinuation (up to 81.30 months) |
| Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score | The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates. | Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36 |
| Change From Baseline in EuroQol-5D (EQ-5D) Score | The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates. | Baseline, Month 6; Baseline, Month 24; Baseline, Month 33 |
| Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells | Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB. | Baseline to 24 months (2 years) |
| Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression | Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining). | Baseline to 94.5 months |
| Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte | Month 2, Month 4: Predose |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Los Angeles | California | 90095 | United States |
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Placebo administered PO QD after an initial loading dose of placebo on Day 1.
| Received At Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-To-Treat (ITT): All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin: Arm A - Experimental | Enzastaurin 500 mg administered PO QD after an initial loading dose of 1125 mg on Day 1. |
| BG001 | Placebo: Arm B - Control | Placebo administered PO QD after an initial loading dose of placebo on Day 1. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Overall Disease-Free Survival | Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy. | All randomized participants. DFS is censored at the last assessable disease free assessment for participants who are alive or have not progressed. The number of censored participant data for enzastaurin and placebo is 369 (73.2%) and 180 (70.9%), respectively. | Posted | Median | 95% Confidence Interval | Month | Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Free Survival at 2 Years | Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method. | All randomized participants. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline to 2 Years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival | Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy. | All randomized participants. EFS is censored at the last assessable disease-free assessment for participants who are alive, have not progressed or started new anticancer treatment. The number of censored participant data for enzastaurin and placebo is 364 (72.2%) and 176 (69.3%), respectively. | Posted | Number | Month | Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival at 2 Years | Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method. | All randomized participants. | Posted | Number | 95% Confidence Interval | Proportion of participants | Baseline to 2 Years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause. | All randomized participants. Overall survival is censored at the last date of contact for participants who have no reported death. The number of censored participant data for enzastaurin and placebo is 404 (80.2%) and 205 (80.7%), respectively. | Posted | Number | Month | Baseline to Date of Death from Any Cause (up to 80.30 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | Number of participants with treatment-emergent adverse events. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | First dose through 30 days post-study treatment discontinuation (up to 81.30 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score | The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates. | All randomized participants who completed at least one FACT-Lym assessment. | Posted | Mean | Standard Error | Units on a Scale | Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQol-5D (EQ-5D) Score | The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates. | All randomized participants who completed at least one EQ-5D assessment. | Posted | Mean | Standard Error | Units on a Scale | Baseline, Month 6; Baseline, Month 24; Baseline, Month 33 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells | Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB. | All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to 24 months (2 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression | Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining). | All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to 94.5 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte | All participants who received at least one dose of the study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/liter (nmol/L) | Month 2, Month 4: Predose |
|
|
Not provided
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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: Arm A - Experimental | Administered orally as four 125-mg tablets daily (after an initial loading dose of three 125-mg tablets given three times on Day 1) | 135 | 493 | 406 | 493 | ||
| EG001 | Placebo: Arm B - Control | Administered orally as four tablets daily (after an initial loading dose of three tablets given three times on Day 1) | 72 | 249 | 185 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ophthalmoplegia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anal prolapse | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gingivitis ulcerative | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Jejunal perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oral lichen planus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pseudopolyposis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Volvulus of small bowel | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Multi-organ disorder | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cervicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic cyst infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatitis b | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatitis c | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Infectious peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Myelitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Scrub typhus | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Maternal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebellar tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Diffuse large b-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Basal ganglia infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cranial nerve paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tongue paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tonic convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vith nerve paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin fibrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal hernia repair | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Anal fissure excision | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Meniscus removal | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal fusion surgery | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
Not provided
Not provided
Not provided
| Male |
|
| Caucasian |
|
| East Asian |
|
| Hispanic |
|
| Native American |
|
| West Asian (Indian sub-continent) |
|
| Belgium |
|
| Brazil |
|
| Canada |
|
| China |
|
| Czechia |
|
| Germany |
|
| Denmark |
|
| Spain |
|
| Finland |
|
| France |
|
| Greece |
|
| Hungary |
|
| India |
|
| Italy |
|
| Japan |
|
| South Korea |
|
| Mexico |
|
| Poland |
|
| Puerto Rico |
|
| Portugal |
|
| Sweden |
|
| Taiwan |
|
| United Kingdom |
|
| United States |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Placebo administered PO QD after an initial loading dose of placebo on Day 1.Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells. |
| OG003 | Placebo Arm B- Control With Non-germinal-center B-cells | Placebo administered PO QD after an initial loading dose of placebo on Day 1. Participants from the placebo treatment group with diffuse large B-cell lymphoma expression profile not similar to germinal-center B-cells. |
|
|
|
| OG003 | Placebo: Arm B With PKC-β2 Cytoplasm (Low Expression) | Participants from placebo treatment group with PKC-β2 cytoplasmic protein expression. |
|
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|