ENGAGE-501: A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of entinostat, SNDX-275, in patients with relapsed or refractory Hodgkin's lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Entinostat Regimen determined by protocol version. Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. |
Drug: Entinostat
Entinostat tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Best Overall Response Based on the Participant's Best Response That is Documented Within the First 6 Cycles of Protocol Therapy [Up to 6 months]
Best Overall Response was defined as Complete Response (CR) or Partial Response (PR). Tumor response was assessed by the Investigators using the International Working Group revised response criteria for malignant lymphoma (Cheson, Pfistner et al. 2007). CR was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to HL. PR was defined as: At least a 50% decrease in sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses, No increase in the size of other nodes, No new sites of disease.
Secondary Outcome Measures
- Percentage of Participants With Best Overall Response Based on the Participant's Best Response Documented Through the Entire Course of Protocol Therapy [Regimen 1 and 2 median follow-up 36.6 months; Regimen 3 median follow-up 18.4 months]
Best Overall Response was defined as Complete Response (CR) or Partial Response (PR). Tumor response was assessed by the Investigators using the International Working Group revised response criteria for malignant lymphoma (Cheson, Pfistner et al. 2007). CR was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to HL. PR was defined as: At least a 50% decrease in sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses, No increase in the size of other nodes, No new sites of disease.
- Duration of Objective Response for Participants Achieving CR or PR [Regimen 1 and 2 median follow-up 36.6 months; Regimen 3 median follow-up 18.4 months]
Duration of objective response was defined as the number of days from the start date of CR or PR (whichever status is recorded first), until the first date that recurrent or progressive disease was objectively documented.
- Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AEs) [First dose to within 30 days of the last dose of study drug (Up to 34 months)]
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Treatment-Emergent Adverse Event (TEAE) is an AE that occurred after receive study drug. Any changes from baseline in vital signs, electrocardiogram results, and laboratory parameters assessed by the investigator to be clinically significant were reported as AEs. A SAE is defined as an AE that: is fatal, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect, is another significant medical hazard, such as new malignancy.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pathologic confirmation of relapsed or refractory classical Hodgkin's lymphoma from the last biopsy available. Relapsed disease is defined as progressive disease following systematic therapy(ies) with curative intent. Refractory disease is defined as disease not responding to or having progressed within 3 months of the last dose of most recent systemic therapy.
-
Must have progressed after, or been ineligible for, stem cell transplantation.
-
Documented disease that is radiographically measurable (≥ 1.5 cm in the largest transverse dimension). If only 1 site of radiographically measurable lesion with the longest diameter < 2.5 cm, lesion must be positive by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) or biopsy.
-
Last dose of cytotoxic chemotherapy must be > 21 days before the first dose of study drug.
-
European Cooperative Oncology Group (ECOG) performance status of 0 or 1.
-
Age 18 years or older.
-
Total Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) and Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 2.5 x ULN, possible exceptions if documented Hodgkin Lymphoma (HL) liver involvement.
-
Serum Creatinine ≤ 1.5 x ULN.
-
Absolute neutrophil counts of ≥ 1,000/µL, and platelet counts ≥ 50,000/µL
-
Patients or their legal representative must be able to read, understand, and sign a written informed consent
Exclusion Criteria:
-
Patients with another active cancer (excluding basal cell carcinoma or CIN/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed, excluding active disease within the prior 5 years.
-
Prior allogeneic stem cell transplantation requiring active immunosuppressive therapy within 3 months of registration or with evidence of active Graft Versus Host Disease (GVHD).
-
Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test prior to start of study drug.
-
WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following the last dose of study drug.
-
Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5⁰C that has not been evaluated for infection on the day of scheduled dosing.
-
Patients who have been treated with any investigational drug within 28 days prior to the first dose of study medication, or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
-
Prior treatment with Histone Deacetylase (HDAC) inhibitors (e.g. valproic acid, Zolinza (SAHA), romidepsin (Istodax),and experimental compounds such as MethylGene's MCGD0103 and Novartis' LBH589).
-
History of pericarditis or pericardial effusion that had required medical or surgical intervention in the last 6 months, or myocardial infarction or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease or a QTc interval >0.47 seconds.
-
Known human immunodeficiency virus (HIV) or a history of active Hepatitis B or C as evidenced by laboratory abnormalities in addition to positive serology.
-
Active central nervous system lymphoma and lymphoma with leptomeningeal involvement.
-
Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and comply with study procedures.
-
Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
-
History of gastrointestinal disorders (medical disorder or extensive surgery) that could interfere with absorption of study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tower Cancer Research Foundation | Beverly Hills | California | United States | |
| 2 | University of Colorado | Denver | Colorado | United States | |
| 3 | Johns Hopkins | Baltimore | Maryland | United States | |
| 4 | University of Nebraska Medical Center | Omaha | Nebraska | United States | |
| 5 | Roswell Park Cancer Institute | Buffalo | New York | United States | |
| 6 | MD Anderson Cancer Center | Houston | Texas | United States |
Sponsors and Collaborators
- Syndax Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNDX-275-0501
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 6 investigative sites in the United States from 13 April 2009 to 8 February 2013. |
|---|---|
| Pre-assignment Detail | Participants with a diagnosis of Relapsed or Refractory Hodgkin's Lymphoma (HL) were enrolled into one of three entinostat dosing regimens based on the version of the protocol at their time of enrollment in the study. |
| Arm/Group Title | Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg |
|---|---|---|---|
| Arm/Group Description | Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. |
| Period Title: Overall Study | |||
| STARTED | 16 | 17 | 16 |
| COMPLETED | 11 | 10 | 4 |
| NOT COMPLETED | 5 | 7 | 12 |
Baseline Characteristics
| Arm/Group Title | Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg | Total |
|---|---|---|---|---|
| Arm/Group Description | Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. | Total of all reporting groups |
| Overall Participants | 16 | 17 | 16 | 49 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
32.8
(10.33)
|
37.4
(13.53)
|
34.8
(10.31)
|
35.0
(11.45)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
9
56.3%
|
5
29.4%
|
10
62.5%
|
24
49%
|
| Male |
7
43.8%
|
12
70.6%
|
6
37.5%
|
25
51%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Asian |
1
6.3%
|
0
0%
|
0
0%
|
1
2%
|
| Black or African American |
2
12.5%
|
0
0%
|
0
0%
|
2
4.1%
|
| White |
10
62.5%
|
17
100%
|
15
93.8%
|
42
85.7%
|
| Other |
3
18.8%
|
0
0%
|
1
6.3%
|
4
8.2%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
16
100%
|
17
100%
|
16
100%
|
49
100%
|
Outcome Measures
| Title | Percentage of Participants With Best Overall Response Based on the Participant's Best Response That is Documented Within the First 6 Cycles of Protocol Therapy |
|---|---|
| Description | Best Overall Response was defined as Complete Response (CR) or Partial Response (PR). Tumor response was assessed by the Investigators using the International Working Group revised response criteria for malignant lymphoma (Cheson, Pfistner et al. 2007). CR was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to HL. PR was defined as: At least a 50% decrease in sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses, No increase in the size of other nodes, No new sites of disease. |
| Time Frame | Up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol (PP) population included all participants who met all of the following criteria: Completed at least 2 cycles of entinostat therapy and Underwent computed tomography (CT) or positron emission tomography (PET) scans at Screening and Day 1 of Cycle 3. |
| Arm/Group Title | Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg |
|---|---|---|---|
| Arm/Group Description | Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. |
| Measure Participants | 12 | 17 | 12 |
| Number (95% Confidence Interval) [percentage of participants] |
8.3
51.9%
|
11.8
69.4%
|
16.7
104.4%
|
| Title | Percentage of Participants With Best Overall Response Based on the Participant's Best Response Documented Through the Entire Course of Protocol Therapy |
|---|---|
| Description | Best Overall Response was defined as Complete Response (CR) or Partial Response (PR). Tumor response was assessed by the Investigators using the International Working Group revised response criteria for malignant lymphoma (Cheson, Pfistner et al. 2007). CR was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to HL. PR was defined as: At least a 50% decrease in sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses, No increase in the size of other nodes, No new sites of disease. |
| Time Frame | Regimen 1 and 2 median follow-up 36.6 months; Regimen 3 median follow-up 18.4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all participants who met all of the following criteria: Completed at least 2 cycles of entinostat therapy and Underwent CT or PET scans at Screening and Day 1 of Cycle 3. |
| Arm/Group Title | Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg |
|---|---|---|---|
| Arm/Group Description | Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. |
| Measure Participants | 12 | 17 | 12 |
| Number (95% Confidence Interval) [percentage of participants] |
8.3
51.9%
|
17.6
103.5%
|
16.7
104.4%
|
| Title | Duration of Objective Response for Participants Achieving CR or PR |
|---|---|
| Description | Duration of objective response was defined as the number of days from the start date of CR or PR (whichever status is recorded first), until the first date that recurrent or progressive disease was objectively documented. |
| Time Frame | Regimen 1 and 2 median follow-up 36.6 months; Regimen 3 median follow-up 18.4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| PP population included all participants who met all of the following criteria: Completed at least 2 cycles of entinostat therapy and Underwent CT or PET scans at Screening and Day 1 of Cycle 3. Analysis included all participants who achieved CR or PR. |
| Arm/Group Title | Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg |
|---|---|---|---|
| Arm/Group Description | Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. |
| Measure Participants | 1 | 3 | 2 |
| Median (95% Confidence Interval) [months] |
NA
|
28.6
|
8.3
|
| Title | Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AEs) |
|---|---|
| Description | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Treatment-Emergent Adverse Event (TEAE) is an AE that occurred after receive study drug. Any changes from baseline in vital signs, electrocardiogram results, and laboratory parameters assessed by the investigator to be clinically significant were reported as AEs. A SAE is defined as an AE that: is fatal, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect, is another significant medical hazard, such as new malignancy. |
| Time Frame | First dose to within 30 days of the last dose of study drug (Up to 34 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received at least one dose of study drug. |
| Arm/Group Title | Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg |
|---|---|---|---|
| Arm/Group Description | Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. |
| Measure Participants | 16 | 17 | 16 |
| Any TEAE |
16
100%
|
17
100%
|
16
100%
|
| SAE |
2
12.5%
|
7
41.2%
|
3
18.8%
|
Adverse Events
| Time Frame | First dose of study drug to within 30 days of last dose (Up to 34 months) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg | |||
| Arm/Group Description | Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. | Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. | |||
All Cause Mortality |
||||||
| Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
Serious Adverse Events |
||||||
| Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/16 (12.5%) | 7/17 (41.2%) | 3/16 (18.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Thrombocytopenia | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Febrile neutropenia | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Neutropenia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cardiac disorders | ||||||
| Cardio-respiratory arrest | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Pericardial effusion | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Pericarditis | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Endocrine disorders | ||||||
| Hypothyroidism | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| General disorders | ||||||
| Pyrexia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hepatobiliary disorders | ||||||
| Cholangitis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Infections and infestations | ||||||
| Liver abscess | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Sepsis | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hypercalcaemia | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Hyponatraemia | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Psychiatric disorders | ||||||
| Panic attack | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Renal and urinary disorders | ||||||
| Nephrolithiasis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute respiratory distress syndrome | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Lung infection pseudomonal | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pulmonary embolism | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Respiratory failure | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Vascular disorders | ||||||
| Subdural haemorrhage | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Regimen 1: Entinostat 10 mg | Regimen 2: Entinostat 10 mg/15 mg | Regimen 3: Entinostat 15 mg | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/16 (100%) | 17/17 (100%) | 16/16 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Thrombocytopenia | 10/16 (62.5%) | 11/17 (64.7%) | 12/16 (75%) | |||
| Anaemia | 9/16 (56.3%) | 9/17 (52.9%) | 10/16 (62.5%) | |||
| Neutropenia | 9/16 (56.3%) | 6/17 (35.3%) | 9/16 (56.3%) | |||
| Leukopenia | 2/16 (12.5%) | 3/17 (17.6%) | 1/16 (6.3%) | |||
| Lymph node pain | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Lymphopenia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cardiac disorders | ||||||
| Tachycardia | 1/16 (6.3%) | 3/17 (17.6%) | 3/16 (18.8%) | |||
| Pericardial effusion | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Atrial fibrillation | 0/16 (0%) | 1/17 (5.9%) | 1/16 (6.3%) | |||
| Angina pectoris | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Atrial flutter | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cardiac arrest | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cardiac failure chronic | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cardiac failure congestive | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cardiomegaly | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cardiomyopathy | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Pericardial rub | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Sinus bradycardia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Ear infection | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Endocrine disorders | ||||||
| Hypothyroidism | 0/16 (0%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Adrenal insufficiency | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hyperparathyroidism | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Eye disorders | ||||||
| Vision blurred | 1/16 (6.3%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Conjunctivitis | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Dry eye | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Eye irritation | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Photophobia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 2/16 (12.5%) | 12/17 (70.6%) | 7/16 (43.8%) | |||
| Constipation | 5/16 (31.3%) | 7/17 (41.2%) | 3/16 (18.8%) | |||
| Vomiting | 3/16 (18.8%) | 10/17 (58.8%) | 1/16 (6.3%) | |||
| Diarrhoea | 1/16 (6.3%) | 8/17 (47.1%) | 3/16 (18.8%) | |||
| Abdominal pain | 1/16 (6.3%) | 5/17 (29.4%) | 0/16 (0%) | |||
| Dyspepsia | 1/16 (6.3%) | 3/17 (17.6%) | 0/16 (0%) | |||
| Dry mouth | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Dysphagia | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Gastritis | 0/16 (0%) | 0/17 (0%) | 2/16 (12.5%) | |||
| Gastrooesophageal reflux disease | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Abdominal discomfort | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Abdominal distension | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Abdominal pain upper | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Abdominal tenderness | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Anal fissure | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Dysgeusia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Faeces hard | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Flatulence | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Gingival bleeding | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Gingivitis | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Oral candidiasis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Rectal haemorrhage | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Stomach discomfort | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Tongue coated | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Tooth abscess | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| General disorders | ||||||
| Fatigue | 7/16 (43.8%) | 7/17 (41.2%) | 5/16 (31.3%) | |||
| Pyrexia | 3/16 (18.8%) | 7/17 (41.2%) | 3/16 (18.8%) | |||
| Chills | 2/16 (12.5%) | 3/17 (17.6%) | 3/16 (18.8%) | |||
| Asthenia | 1/16 (6.3%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Pain | 1/16 (6.3%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Gait disturbance | 1/16 (6.3%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Catheter thrombosis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Chest discomfort | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Chest pain | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Condition aggravated | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Crepitations | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Early satiety | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Exercise tolerance decreased | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Irritability | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Malaise | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Mucosal dryness | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Mucosal inflammation | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Multi-organ failure | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Oedema | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pitting oedema | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hepatobiliary disorders | ||||||
| Oedema peripheral | 5/16 (31.3%) | 7/17 (41.2%) | 3/16 (18.8%) | |||
| Bile duct stone | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cholangitis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hepatomegaly | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hyperbilirubinaemia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Jaundice | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Immune system disorders | ||||||
| Drug hypersensitivity | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hypogammaglobulinaemia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Transfusion reaction | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Infections and infestations | ||||||
| Sepsis | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Herpes zoster | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Lice infestation | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Localised infection | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Septic shock | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Sinusitis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Foreign body trauma | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Post procedural haemorrhage | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Investigations | ||||||
| Blood creatinine increased | 1/16 (6.3%) | 3/17 (17.6%) | 1/16 (6.3%) | |||
| Aspartate aminotransferase increased | 2/16 (12.5%) | 1/17 (5.9%) | 1/16 (6.3%) | |||
| Neutrophil count decreased | 0/16 (0%) | 2/17 (11.8%) | 2/16 (12.5%) | |||
| Platelet count decreased | 1/16 (6.3%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Alanine aminotransferase increased | 2/16 (12.5%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Blood alkaline phosphatase increased | 1/16 (6.3%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Blood bilirubin increased | 2/16 (12.5%) | 0/17 (0%) | 0/16 (0%) | |||
| Blood lactate dehydrogenase increased | 1/16 (6.3%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Weight decreased | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Weight increased | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| White blood cell count decreased | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Blood creatinine | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Blood glucose increased | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Electrocardiogram QT prolonged | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Eosinophil percentage increased | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| International normalised ratio decreased | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Monocyte count increased | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypokalaemia | 3/16 (18.8%) | 2/17 (11.8%) | 4/16 (25%) | |||
| Hypophosphataemia | 1/16 (6.3%) | 4/17 (23.5%) | 4/16 (25%) | |||
| Anorexia | 0/16 (0%) | 3/17 (17.6%) | 2/16 (12.5%) | |||
| Dehydration | 0/16 (0%) | 1/17 (5.9%) | 3/16 (18.8%) | |||
| Hypoalbuminaemia | 2/16 (12.5%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Decreased appetite | 0/16 (0%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Hypercalcaemia | 1/16 (6.3%) | 1/17 (5.9%) | 1/16 (6.3%) | |||
| Hypocalcaemia | 0/16 (0%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Hyperglycaemia | 0/16 (0%) | 1/17 (5.9%) | 1/16 (6.3%) | |||
| Hypomagnesaemia | 1/16 (6.3%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Hyponatraemia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Cachexia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hyperphosphataemia | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Hypoglycaemia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Increased appetite | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Bone pain | 1/16 (6.3%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Back pain | 0/16 (0%) | 1/17 (5.9%) | 2/16 (12.5%) | |||
| Muscle spasms | 1/16 (6.3%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Muscular weakness | 1/16 (6.3%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Musculoskeletal chest pain | 2/16 (12.5%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Musculoskeletal pain | 0/16 (0%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Arthralgia | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Flank pain | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Joint stiffness | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Musculoskeletal discomfort | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Myalgia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Neck pain | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pain in extremity | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Pain in jaw | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Nervous system disorders | ||||||
| Headache | 4/16 (25%) | 6/17 (35.3%) | 4/16 (25%) | |||
| Dizziness | 0/16 (0%) | 3/17 (17.6%) | 0/16 (0%) | |||
| Neuropathy peripheral | 1/16 (6.3%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Aphasia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Critical illness polyneuropathy | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Depressed level of consciousness | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Dysarthria | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Dyskinesia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Facial paresis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Hyperaesthesia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Lethargy | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Paraesthesia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Spinal cord compression | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Tremor | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Breath sounds abnormal | 1/16 (6.3%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Haemoglobin decreased | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 1/16 (6.3%) | 3/17 (17.6%) | 1/16 (6.3%) | |||
| Confusional state | 0/16 (0%) | 1/17 (5.9%) | 2/16 (12.5%) | |||
| Anxiety | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Agitation | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Delirium | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Depression | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Mental status changes | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Mood altered | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Renal and urinary disorders | ||||||
| Urinary tract infection | 0/16 (0%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Dysuria | 0/16 (0%) | 1/17 (5.9%) | 1/16 (6.3%) | |||
| Calculus bladder | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Micturition urgency | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pollakiuria | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Proteinuria | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Renal failure | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Urinary incontinence | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Benign prostatic hyperplasia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Epididymitis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Scrotal oedema | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 3/16 (18.8%) | 5/17 (29.4%) | 4/16 (25%) | |||
| Cough | 4/16 (25%) | 4/17 (23.5%) | 2/16 (12.5%) | |||
| Upper respiratory tract infection | 1/16 (6.3%) | 6/17 (35.3%) | 1/16 (6.3%) | |||
| Epistaxis | 2/16 (12.5%) | 2/17 (11.8%) | 2/16 (12.5%) | |||
| Dyspnoea exertional | 1/16 (6.3%) | 3/17 (17.6%) | 1/16 (6.3%) | |||
| Pneumonia | 0/16 (0%) | 1/17 (5.9%) | 3/16 (18.8%) | |||
| Productive cough | 0/16 (0%) | 2/17 (11.8%) | 2/16 (12.5%) | |||
| Sinusitis | 0/16 (0%) | 2/17 (11.8%) | 2/16 (12.5%) | |||
| Rhinitis | 0/16 (0%) | 1/17 (5.9%) | 2/16 (12.5%) | |||
| Wheezing | 0/16 (0%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Nasal congestion | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Nasopharyngitis | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pharyngolaryngeal pain | 1/16 (6.3%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Pleural effusion | 0/16 (0%) | 1/17 (5.9%) | 1/16 (6.3%) | |||
| Rhinorrhoea | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Sinus congestion | 0/16 (0%) | 1/17 (5.9%) | 1/16 (6.3%) | |||
| Acute respiratory failure | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Acute sinusitis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Haemoptysis | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Hypoxia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Lung infiltration | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Nasal dryness | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Nasal ulcer | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Pharyngitis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pleuritic pain | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pneumocystis jiroveci pneumonia | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pneumonia klebsiella | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Pulmonary alveolar haemorrhage | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Rales | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Respiratory tract congestion | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Sinus headache | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Throat irritation | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 2/16 (12.5%) | 3/17 (17.6%) | 1/16 (6.3%) | |||
| Rash | 0/16 (0%) | 3/17 (17.6%) | 1/16 (6.3%) | |||
| Contusion | 1/16 (6.3%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Hyperhidrosis | 0/16 (0%) | 2/17 (11.8%) | 1/16 (6.3%) | |||
| Dry skin | 1/16 (6.3%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Ecchymosis | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Madarosis | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Night sweats | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Pain of skin | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Rash erythematous | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Skin candida | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Skin discolouration | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Subcutaneous abscess | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Vascular disorders | ||||||
| Hypotension | 1/16 (6.3%) | 2/17 (11.8%) | 0/16 (0%) | |||
| Deep vein thrombosis | 1/16 (6.3%) | 0/17 (0%) | 0/16 (0%) | |||
| Orthostatic hypotension | 0/16 (0%) | 1/17 (5.9%) | 0/16 (0%) | |||
| Pallor | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Shock | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
| Thrombosis | 0/16 (0%) | 0/17 (0%) | 1/16 (6.3%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a period of 18 months until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
Results Point of Contact
| Name/Title | Michael L. Meyers, MD, PhD, Chief Medical Officer |
|---|---|
| Organization | Syndax Pharmaceuticals, Inc. |
| Phone | +1-646-690-7620 |
| mmeyers@syndax.com |
- SNDX-275-0501