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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003016-35 | EudraCT Number |
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This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panobinostat | Experimental | Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat | Drug | Panobinostat hard gelatin capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation. | From the start of the treatment of last participant up to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | Best overall radiological response (CT/MRI) was recorded from start of treatment until progression/ recurrence. CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation. |
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Inclusion Criteria:
Participant age is ≥ 18 years.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Participant has a history of classical Hodgkin's Lymphoma (HL) (i.e. Nodular sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte depleted).
Participant has progressive disease after receiving high dose chemotherapy with autologous hematopoietic stem cell transplant (AHSCT).
Note: If last therapy was ≥ 18 months ago, then biopsy should be performed to confirm diagnosis.
Note: Participant should have received ≤ 5 prior systemic treatment regimens (See Post-text supplement 2 for definitions and examples).
Note: Participant will be allowed on study who have also received an allogeneic hematopoietic stem cell transplant, however this therapy alone is not sufficient for inclusion into this study.
Participant has at least one site of measurable nodal disease at baseline ≥ 2.0 centimeter (cm) in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by computed tomography (CT) scan (magnetic resonance imaging [MRI] is allowed only if CT scan can not be performed).
Note: Participant with bone marrow involvement are eligible, but this criteria alone should not be used for disease measurement.
Participant has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail):
Note: Potassium, calcium, magnesium, sodium, and/or phosphorus supplements may be given to correct values that are < lower limits of normal (LLN). Post-correction values must not be deemed to be a clinically significant abnormality prior to participant being dosed.
Clinically euthyroid. Note: Participants are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
Written informed consent was obtained from the participant prior to any study-specific screening procedures.
Participant has the ability to swallow capsules or tablets.
Exclusion Criteria:
Participant has a history of prior treatment with a deacetylase (DAC) inhibitor including panobinostat.
Participant will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment.
Participant has been treated with monoclonal antibody therapy (e.g., rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment.
Participant has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1.
Participant has been treated with > 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples).
Participant has received prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to ≤ grade 1.
Participant is using any anti-cancer therapy concomitantly.
Participant treated with allogeneic hematopoietic stem cell transplant who is currently on or has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD).
Participant has a history of another primary malignancy ≤ 3 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
Participant has a history of central nervous system (CNS) involvement with lymphoma.
Participant has impaired cardiac function including any of the following:
Participant has any other clinically significant heart disease (e.g., uncontrolled hypertension).
Participant has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection).
Participant has unresolved diarrhea ≥ grade 2.
Participant has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol.
Participant has a known history of human immunodeficiency virus (HIV) seropositivity (screening HIV testing is not required).
Participant is using medications that have a relative risk of prolonging the QT interval or of inducing Torsade de Pointes, where such treatment cannot be discontinued or switched to a different medication prior to starting study drug.
Participant is a woman who is pregnant or breast feeding, or a women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study through 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). WOCBP must have a negative serum pregnancy test at baseline.
Male participant whose sexual partner(s) are WOCBP who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment.
Participants with any of the following contraindications to positron emission tomography (PET) are excluded from the [18F]- fludeoxyglucose (FDG) PET study (only applicable for centers participating in the PET study):
Fasting blood glucose above 200 milligrams per deciliter (mg/dL), at time of PET scan.
Inability to lay down for 60 minutes or has a history of claustrophobia.
Participant not at a participating center.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(2) | Duarte | California | 91010-3000 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29296798 | Derived | Chari A, Cho HJ, Dhadwal A, Morgan G, La L, Zarychta K, Catamero D, Florendo E, Stevens N, Verina D, Chan E, Leshchenko V, Lagana A, Perumal D, Mei AH, Tung K, Fukui J, Jagannath S, Parekh S. A phase 2 study of panobinostat with lenalidomide and weekly dexamethasone in myeloma. Blood Adv. 2017 Aug 21;1(19):1575-1583. doi: 10.1182/bloodadvances.2017007427. eCollection 2017 Aug 22. | |
| 23822537 |
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A total of 102 participants were to be enrolled and treated in the study. However, 129 participants got enrolled and analyzed, out of which no participant completed the study.
Participants were enrolled at 45 sites in 13 countries from 16 September 2008 to 12 August 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panobinostat | Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years) |
| Time To Overall Disease Response in Responders | Time to overall disease response (CR or PR) was defined as the time from the date of randomization/start of treatment to the date of first documented disease response (PR or CR). Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study as per Investigator's assessment. | From the start of treatment up to approximately 5 years |
| Duration of Overall Disease Response | Duration of overall response (CR or PR) was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study. | From the start of treatment up to approximately 5 years |
| Progression Free Survival (PFS) | Progression-free survival (PFS) was defined as the time from the date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a participant has not had an event, progression-free survival was censored at the date of the last adequate assessment. | From the start of treatment up to approximately 5 years |
| The Overall Survival (OS) | OS was the duration from date of randomization to date of death from any cause. If a participant has not had an event, overall survival was censored at the date of the last adequate assessment. | Baseline to date of death from any cause (up to approximately 5 years) |
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat | An AE is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) occurring after signing the informed consent even if the event is not considered to be related to the study drug(s). SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality. | Up to approximately 5 years |
| Maximum Observed Concentration (Cmax) of Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
| The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
| Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Georgia Regents University Cancer Clinical Research Unit | Augusta | Georgia | 30912 | United States |
| Rush University Medical Center Divisionof Hem/Onc Research(2) | Chicago | Illinois | 60612 | United States |
| VA Maryland Health Care Dept.of GreenbaumCancerCent(5) | Baltimore | Maryland | 21201 | United States |
| Dana Farber Cancer Institute Hematology / Oncology | Boston | Massachusetts | 02115 | United States |
| Karmanos Cancer Institute Div.of Hematology/Oncology | Detroit | Michigan | 48201 | United States |
| Mayo Clinic - Rochester Hematology | Rochester | Minnesota | 55905 | United States |
| University of Pennsylvania Medical Center Dept of UPenn Med Ctr (3) | Philadelphia | Pennsylvania | 19104-4283 | United States |
| University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3) | Houston | Texas | 77030-4009 | United States |
| The Methodist Hospital Cell & Gene Therapy Clinic | Houston | Texas | 77030 | United States |
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) | San Antonio | Texas | 78229 | United States |
| West Virginia University/ Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506 | United States |
| Novartis Investigative Site | Herston | Queensland | 4029 | Australia |
| Novartis Investigative Site | Malvern | Victoria | 3144 | Australia |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Charleroi | 6000 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
| Novartis Investigative Site | Campinas | São Paulo | 13083-970 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01224-000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05403-000 | Brazil |
| Novartis Investigative Site | Dijon | 21034 | France |
| Novartis Investigative Site | Lille | 59 037 | France |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Marseille | 13273 | France |
| Novartis Investigative Site | Rennes | 35019 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Beersheba | 84101 | Israel |
| Novartis Investigative Site | Jerusalem | 91120 | Israel |
| Novartis Investigative Site | Ramat Gan | 52621 | Israel |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Udine | UD | 33100 | Italy |
| Novartis Investigative Site | Kuala Selangor | 68000 | Malaysia |
| Novartis Investigative Site | Auckland | New Zealand |
| Novartis Investigative Site | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Barcelona | Catalonia | 08025 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| Novartis Investigative Site | Withington | Greater Manchester | M20 4BX | United Kingdom |
| Novartis Investigative Site | Southampton | United Kingdom |
| Derived |
| Harrison SJ, Hsu AK, Neeson P, Younes A, Sureda A, Engert A, Prince HM, Li M, Savage P, Bugarini R, Williams D, Squier M, Ritchie DS. Early thymus and activation-regulated chemokine (TARC) reduction and response following panobinostat treatment in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant. Leuk Lymphoma. 2014 May;55(5):1053-60. doi: 10.3109/10428194.2013.820287. Epub 2013 Aug 5. |
| COMPLETED | Deaths reported included deaths that occurred more than 28 days after treatment discontinuation. |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Panobinostat | Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months). |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
|
| 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 | Objective Response Rate (ORR) as Assessed by the Investigator Based on Cheson Response Criteria | ORR was number of participants with best overall disease response of complete response(CR)/partial response(PR).Best overall disease response was best disease response recorded from start of treatment until disease progression/recurrence.CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation. | Full analysis set (FAS) included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From the start of the treatment of last participant up to 32 weeks |
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| Secondary | Response Rate Based on Central Review of Computed Tomography (CT) Scan/Magnetic Resonance Imaging (MRI) | Best overall radiological response (CT/MRI) was recorded from start of treatment until progression/ recurrence. CR=complete normalization of all index nodal,extranodal lesions,complete disappearance of all extranodal lesions.PR=50% decrease in SPD for up to 6 identified dominant lesions (splenic,hepatic nodules) from baseline.Stable=neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease (PD), reference smallest sum diameters while on study.Progression=50% increase in sum of longest diameter of all target lesions,from smallest sum of longest diameter of all target lesions recorded at or after baseline/a new lesion/progression of non-target lesions.Unknown is progression not documented,one/more of index lesions not assessed or have been assessed using a different method than baseline at the time of radiologic evaluation. | FAS included all participants who received at least one dose of study drug. | Posted | Number | percentage of participants | From start of treatment until progression/recurrence or start of a new cancer therapy (up to approximately 5 years) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Time To Overall Disease Response in Responders | Time to overall disease response (CR or PR) was defined as the time from the date of randomization/start of treatment to the date of first documented disease response (PR or CR). Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study as per Investigator's assessment. | FAS included all participants who received at least one dose of study drug. Participants who were responders among those who were had relapsed/refractory classical Hodgkin's lymphoma were evaluated for this outcome measure. Time to overall disease response was calculated by Kaplan-Meier estimation. | Posted | Median | 95% Confidence Interval | weeks | From the start of treatment up to approximately 5 years |
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| Secondary | Duration of Overall Disease Response | Duration of overall response (CR or PR) was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. Per Cheson response criteria, CR= is a complete normalization of all index nodal and extranodal lesions and complete disappearance of all extranodal lesions. PR= is a 50% decrease in the SPD for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. Participants were considered responders if they had a partial or complete response to a treatment while in the study. | FAS included all participants who received at least one dose of study drug. Participants who were responders among those who were had relapsed/refractory classical Hodgkin's lymphoma were evaluated for this outcome measure. Time to overall disease response was calculated by Kaplan-Meier estimation. | Posted | Median | 95% Confidence Interval | weeks | From the start of treatment up to approximately 5 years |
|
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| Secondary | Progression Free Survival (PFS) | Progression-free survival (PFS) was defined as the time from the date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a participant has not had an event, progression-free survival was censored at the date of the last adequate assessment. | FAS included all participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | From the start of treatment up to approximately 5 years |
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| Secondary | The Overall Survival (OS) | OS was the duration from date of randomization to date of death from any cause. If a participant has not had an event, overall survival was censored at the date of the last adequate assessment. | FAS included all participants who received at least one dose of study drug. | Posted | Median | Full Range | months | Baseline to date of death from any cause (up to approximately 5 years) |
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| Secondary | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), And Deaths as a Measure of Safety and Tolerability of Panobinostat | An AE is the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) occurring after signing the informed consent even if the event is not considered to be related to the study drug(s). SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality. | Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety assessment. | Posted | Number | percentage of participants | Up to approximately 5 years |
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| Secondary | Maximum Observed Concentration (Cmax) of Panobinostat | Pharmacokinetic set (PK) included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
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| Secondary | The Time to Reach Maximum Plasma Concentration (Tmax) of Panobinostat | PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. | Posted | Median | Full Range | hours | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to 28 Hours (AUC0-28) for Panobinostat | PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. | Posted | Mean | Standard Deviation | hour*nanograms per milliliter (h.ng/mL) | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-∞) for Panobinostat | PK population included all participants who have received at least one dose of panobinostat and had sufficient and evaluable blood samples for the Day 1 PK profile. Overall number analyzed is the number of participants with data available for this analyses. | Posted | Mean | Standard Deviation | h.ng/mL | Cycle 1, Day 1: Pre-dose, 0.25, 1, 3, 5, 7, 24, and 28 hours post-dose |
|
|
Up to approximately 5 years
Safety set population included all participants who received at least one dose of study drug and had at least one valid post-baseline safety 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 | Panobinostat | Participants received panobinostat 40 mg, capsules, orally, thrice every week (i.e. days 1, 3 and 5), in each cycle of 21 days until unacceptable toxicity, disease progression, start of new anti-cancer therapy or withdrawal of consent (up to approximately 48 months). | 51 | 129 | 129 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemorrhagic disorder | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Necrotising ulcerative gingivostomatitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cervicitis human papilloma virus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Peripheral nerve lesion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Urethral haemorrhage | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| 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 |
|---|---|
| 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
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Unknown |
|
| Units | Counts |
|---|
| Participants |
|
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| Participants |
|
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