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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000880-27 | EudraCT Number |
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This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously treated with oral bexarotene | Experimental | Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). |
|
| No prior oral bexarotene treatment | Experimental | Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT) | Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as:
| Baseline up to 6 Months of Follow up |
| Measure | Description | Time Frame |
|---|---|---|
| The Overall Response Rate Using mSWAT Skin Score | Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed. | Baseline up to Cycle 12, an average of 12 months |
| Time to Response for Responders |
Not provided
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic | Birmingham | Alabama | 35294-0006 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22981498 | Result | Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbe C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naive patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13. |
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A total 139 Participants were enrolled in the Study. No Patients completed treatment. All patients discontinued the treatment on this study and 136 patients discontinued the study (97.8%). The remaining three patients discontinued the study treatment were immediately transferred to another program.
The study was conducted at 41 centers in 12 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bexarotene Exposed | Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival. |
| Baseline up to Cycle 12, an average of 12 months |
| Duration of Response (DOS) | Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival. | Baseline up to Cycle 12, an average of 12 months |
| Progression-free Survival (PFS) | PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment | Baseline up to Cycle 12, an average of 12 months |
| Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12 | Skin index measurement (Skindex-29) was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess emotions scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed. | Baseline up to Cycle 12, an average of 12 months |
| Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12 | Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess functioning scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed. | Baseline up to Cycle 12, an average of 12 months |
| Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12 | Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed. | Baseline up to Cycle 12, an average of 12 months |
| Maximum Plasma Concentration (Cmax) of Panobinostat | Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL. | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
| Time to Peak Concentration (Tmax) of Panobinostat | Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h. | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
| Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat | AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
| Time of Clast (Tlast) of Panobinostat | Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h. | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
| Last Observed Plasma Concentration (Clast) of Panobinostat | Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast. | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
| City of Hope National Medical Center |
| Duarte |
| California |
| 91010-3000 |
| United States |
| University of California at Los Angeles Dept. of Hematology-Oncology | Los Angeles | California | 90095 | United States |
| Florida Academic Dermatology Center | Miami | Florida | 33136 | United States |
| Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) | Atlanta | Georgia | 30322 | United States |
| Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia | Augusta | Georgia | 30912 | United States |
| NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed | Chicago | Illinois | 60611 | United States |
| Indiana University Dept. of IU Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Boston Medical Center StudyCoordinator:CLBH589B2201 | Boston | Massachusetts | 02118 | United States |
| Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3) | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health System Michigan HouseClinTrialsOffice | Ann Arbor | Michigan | 48109 | United States |
| Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr | Winston-Salem | North Carolina | 27157 | United States |
| University Dermatology Consultants | Cincinnati | Ohio | 45219 | United States |
| Oregon Health & Science University Dept. of OHSU Cancer Institute | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Medical Center Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | United States |
| MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201 | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1221ADC | Argentina |
| Novartis Investigative Site | Buenos Aires | C1425AUM | Argentina |
| Novartis Investigative Site | South Brisbane | Queensland | 4101 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3050 | Australia |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Yvoir | 5530 | Belgium |
| Novartis Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3T 1E2 | Canada |
| Novartis Investigative Site | Helsinki | 00250 HUS | Finland |
| Novartis Investigative Site | Lyon | Cedex 02 | 69288 | France |
| Novartis Investigative Site | Créteil | 94010 | France |
| Novartis Investigative Site | Paris | 75010 | France |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Minden | 32423 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Budapest | H-1085 | Hungary |
| Novartis Investigative Site | Ancona | AN | 60126 | Italy |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Florence | FI | 50129 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Bexarotene Naive |
Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis was performed in Full analyses set (FAS) population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bexarotene Exposed | Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred. |
| BG001 | Bexarotene Naive | Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred. |
| 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 |
|
| 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 Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT) | Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as:
| The analysis was performed in Full Analysis Set (FAS) population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study. | Posted | Number | 95% Confidence Interval | percentage | Baseline up to 6 Months of Follow up |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | The Overall Response Rate Using mSWAT Skin Score | Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed. | The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study. | Posted | Count of Participants | Participants | Baseline up to Cycle 12, an average of 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Response for Responders | Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival. | The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study. | Posted | Median | 95% Confidence Interval | Days | Baseline up to Cycle 12, an average of 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOS) | Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival. | The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study. | Posted | Median | 95% Confidence Interval | Days | Baseline up to Cycle 12, an average of 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment | The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study. | Posted | Median | 95% Confidence Interval | months | Baseline up to Cycle 12, an average of 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12 | Skin index measurement (Skindex-29) was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess emotions scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed. | The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Cycle 12, an average of 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12 | Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess functioning scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed. | The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Cycle 12, an average of 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12 | Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed. | The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Cycle 12, an average of 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of Panobinostat | Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL. | The analysis was performed in PK population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Time to Peak Concentration (Tmax) of Panobinostat | Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h. | The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Median | Full Range | h (hours) | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat | AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. | The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | ng*hr/ml | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Time of Clast (Tlast) of Panobinostat | Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h. | The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Median | Full Range | Hours | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Last Observed Plasma Concentration (Clast) of Panobinostat | Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast. | The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 |
|
|
From Start of the Study up to 7 years approximately
The analysis was performed on Safety analysis population (SAP) consisted of all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
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 | Bexarotene Exposed | Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred. | 3 | 79 | 33 | 79 | 77 | 79 |
| EG001 | Bexarotene Naive | Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). Participants continued treatment until disease progression or unacceptable toxicity occurred. | 3 | 60 | 23 | 60 | 59 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram ST segment depression | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram ST-T segment abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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| Black |
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| Asian |
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| Other |
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