Trial Outcomes & Findings for Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma (NCT NCT01175980)
NCT ID: NCT01175980
Last Updated: 2020-08-03
Results Overview
Objective (Best) response according to RECIST 1.1 criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
Treatment (Vorinostat)
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma
Baseline characteristics by cohort
| Measure |
Treatment (Vorinostat)
n=30 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsObjective (Best) response according to RECIST 1.1 criteria.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=30 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Objective Response According to RECIST 1.1 Criteria
Partial Response
|
2 Participants
|
|
Objective Response According to RECIST 1.1 Criteria
Stable Disease
|
27 Participants
|
|
Objective Response According to RECIST 1.1 Criteria
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsToxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=30 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Menorrhagia
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Mucositis oral
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Non cardiac chest pain
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Oral pain
|
2 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Thromboembolic event
|
2 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Wound complication
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Appendicitis
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Atelectasis
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Bronchial obstruction
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Bronchopulmonary hemorrhage
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Cataract
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Fatigue
|
3 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Headache
|
2 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Hypertension
|
3 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Hypophosphatemia
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Hypoxia
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Lung infection
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte count decreased
|
7 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte count increased
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
Platelet count decreased
|
1 Participants
|
|
Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0
PNEUMONIA
|
1 Participants
|
SECONDARY outcome
Timeframe: From the start of the treatment until the RECIST measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded, assessed up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsPopulation: Only 2 patients achieved a response.
TTR will be summarized descriptively, reporting N, median, mean, standard deviation, standard error (SE), minimum, maximum, and 90% CI for the mean calculated from the SE and asymptotic normal distribution theory.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=2 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Time to Recurrence (TTR)
|
8.85 months
Interval 1.59 to 16.11
|
SECONDARY outcome
Timeframe: From the time measurement criteria are met for CR or PR (whichever is first) until the first date that recurrence or progression is objectively documented, assessed up to 60 months after the last dose of vorinostat max. treatment duration= 24 monthsPopulation: Only 2 patients achieved a response.
Median point estimate and full range will be documented, since only two patients achieved a response.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=2 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Response Duration (RD)
|
30.1 months
Interval 7.2 to 53.0
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 60 months after the last dose of vorinostat maximum treatment duration= 24 monthsDistribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both median point estimate and 90% confidence interval (CI) estimate.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=30 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Progression-free Survival (PFS)
|
11.4 months
Interval 7.1 to 20.5
|
SECONDARY outcome
Timeframe: From the start of treatment until death from any cause, duration for reported probability= 1 year; survival data collected for up to a total of 60 monthsDistribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both point and 90% CI estimates of various statistics of interest can be calculated (e.g., median, 6-month event-free rate, 12-month event-free rate, etc.). Statistical graphs of each K-M curve (with 90% CI lines) will be generated for visual display. (One year survival rate will be given since OS median was not reached due to too few events)
Outcome measures
| Measure |
Treatment (Vorinostat)
n=30 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Overall Survival (OS)
|
88 percentage of participants surviving 1yr
Interval 75.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 56 daysPopulation: We did not have funding to incorporate other imaging modalities, (such as PET/CT), or to utilize other measurement criteria (such as volumetric assessment). Therefore, these data were not collected
Will assess the association between a metabolic response by PET/CT after one course of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria. Will also assess the association between a metabolic response by PET/CT after the first and second chemotherapy courses and PFS.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsPopulation: the two cases that had FFPE blocks for the study
Number of patients with Flow sort diploid populations of tumor cells from FFPE tissue blocks reported as a count of participants.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=2 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Number of Patients With Flow Sort Diploid Populations of Tumor Cells From FFPE Tissue Blocks
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsPopulation: The two cases that had FFPE blocks for the study.
Number of patients with Flow sort aneuploid populations of tumor cells from FFPE tissue. Reported as descriptive results.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=2 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Number of Patients With Flow Sort Aneuploid Populations of Tumor Cells From FFPE Tissue
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsPopulation: The two cases that had FFPE blocks for the study.
Number of patients with Flow sort tetraploid populations of tumor cells from FFPE tissue. Reported as descriptive results.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=2 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Number of Patients With Flow Sort Tetraploid Populations of Tumor Cells From FFPE Tissue
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsPopulation: One of the cases that had FFPE blocks for the study.
Genomic profile of each cell population using oligonucleotide CGH arrays. Reported as unique probes on the CGH array.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=1 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Unique Probes on the Oligonucleotide CGH Array as a Measure of the Genomic Profile of Each Cell Population.
|
442,892 unique probes on the CGH arrays
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsPopulation: One of the cases that had FFPE blocks for the study.
Reported as descriptive results. The combined CGH array and exome data will be mined to identify genes and pathways that are targeted by select somatic events in each of the patient subsets.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=1 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
The Number of Genes Sequenced in the WES Assay as a Measure of the Whole Exome Profile of the Sorted Tumor Population and Matching Germ Line Sample
|
21,522 Genes sequenced in the WES assay.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsSDD will be reported as descriptive results as a median point estimate and a 90% confidence interval (CI) estimate.
Outcome measures
| Measure |
Treatment (Vorinostat)
n=30 Participants
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Stable Disease Duration (SDD)
|
11.4 months
Interval 7.1 to 20.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 monthsPopulation: HR23B was not measured in any participant.
Exact logistic modeling investigation would yield a point and 90% CI estimate of the odds ratio for response.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Vorinostat)
Serious events: 20 serious events
Other events: 30 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Vorinostat)
n=30 participants at risk
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
Gastrointestinal disorders
Appendicitis
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Cataract
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Fatigue
|
10.0%
3/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Vascular disorders
Hypertension
|
10.0%
3/30 • Number of events 7 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Hypoxia
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
PNEUMONIA
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
26.7%
8/30 • Number of events 18 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Mucositis oral
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.7%
2/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Oral pain
|
6.7%
2/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
6.7%
2/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Wound complication
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
Other adverse events
| Measure |
Treatment (Vorinostat)
n=30 participants at risk
Patients receive vorinostat PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Vorinostat: Given PO
|
|---|---|
|
General disorders
Abdominal pain
|
30.0%
9/30 • Number of events 24 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Abducens nerve disorder
|
3.3%
1/30 • Number of events 22 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Activated partial thromboplastin time prolonged
|
10.0%
3/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
36.7%
11/30 • Number of events 41 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
23.3%
7/30 • Number of events 44 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Alopecia
|
56.7%
17/30 • Number of events 131 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Anal pain
|
3.3%
1/30 • Number of events 7 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
15/30 • Number of events 52 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
56.7%
17/30 • Number of events 145 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Anxiety
|
10.0%
3/30 • Number of events 16 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
33.3%
10/30 • Number of events 33 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.3%
1/30 • Number of events 9 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.7%
8/30 • Number of events 18 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Bloating
|
13.3%
4/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
26.7%
8/30 • Number of events 24 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Blurred vision
|
13.3%
4/30 • Number of events 16 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Bronchial infection
|
10.0%
3/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Buttock pain
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Cardiac disorders
Chest pain - cardiac
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Chills
|
16.7%
5/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Conjunctivitis
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Constipation
|
36.7%
11/30 • Number of events 45 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
4/30 • Number of events 9 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
CPK increased
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Renal and urinary disorders
Creatinine increased
|
60.0%
18/30 • Number of events 132 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Dehydration
|
20.0%
6/30 • Number of events 18 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
43.3%
13/30 • Number of events 40 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Ear and labyrinth disorders
Dizziness
|
13.3%
4/30 • Number of events 13 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Dry eye
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Dry mouth
|
16.7%
5/30 • Number of events 28 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
5/30 • Number of events 9 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Dysgeusia
|
33.3%
10/30 • Number of events 87 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Number of events 12 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
4/30 • Number of events 22 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Ear and labyrinth disorders
CERUMEN IMPACTION OF THE RIGHT EAR
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Ear and labyrinth disorders
LEFT EAR CERUMEN
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Vascular disorders
Edema limbs
|
6.7%
2/30 • Number of events 9 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Epistaxis
|
6.7%
2/30 • Number of events 13 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
DOUBLE VISION
|
3.3%
1/30 • Number of events 7 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
REDDENED SCLERA POST OUTSIDE PROCEDURE
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
STYLE LOWER RIGHT EYELID
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Eye infection
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Eye pain
|
3.3%
1/30 • Number of events 6 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Eyelid function disorder
|
3.3%
1/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Facial pain
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Fall
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Fatigue
|
70.0%
21/30 • Number of events 202 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Fever
|
3.3%
1/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Flank pain
|
6.7%
2/30 • Number of events 6 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
3/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Floaters
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Flu like symptoms
|
10.0%
3/30 • Number of events 7 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Flushing
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Gait disturbance
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.3%
1/30 • Number of events 8 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
CHEWING FATIGUE
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
BELCHING
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.7%
2/30 • Number of events 6 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Headache
|
23.3%
7/30 • Number of events 14 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.3%
1/30 • Number of events 12 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Vascular disorders
Hematoma
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Renal and urinary disorders
Hemoglobinuria
|
10.0%
3/30 • Number of events 8 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
6.7%
2/30 • Number of events 8 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
10.0%
3/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Renal and urinary disorders
Hypermagnesemia
|
36.7%
11/30 • Number of events 42 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Vascular disorders
Hypertension
|
43.3%
13/30 • Number of events 73 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
26.7%
8/30 • Number of events 34 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
6.7%
2/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
6.7%
2/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hypokalemia
|
10.0%
3/30 • Number of events 6 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
16.7%
5/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hyponatremia
|
16.7%
5/30 • Number of events 24 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
16.7%
5/30 • Number of events 12 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
3/30 • Number of events 14 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
VIRAL INFECTION
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Injury, poisoning and procedural complications
KNEE INJURY
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Injury, poisoning and procedural complications
BACK INJURY
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Insomnia
|
16.7%
5/30 • Number of events 11 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Investigations
LDH ELEVATED
|
16.7%
5/30 • Number of events 12 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Investigations
ELEVATED BUN
|
3.3%
1/30 • Number of events 9 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Investigations
CREATININE KINASE INCREASED
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
6.7%
2/30 • Number of events 12 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
3.3%
1/30 • Number of events 11 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Vascular disorders
Localized edema
|
3.3%
1/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Lung infection
|
10.0%
3/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
53.3%
16/30 • Number of events 87 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Malaise
|
3.3%
1/30 • Number of events 10 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Memory impairment
|
3.3%
1/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.7%
2/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Metabolism and nutrition disorders
DECREASE IN SERUM PROTEIN
|
3.3%
1/30 • Number of events 6 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
5/30 • Number of events 12 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.3%
7/30 • Number of events 39 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
6.7%
2/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
16.7%
5/30 • Number of events 68 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Nausea
|
60.0%
18/30 • Number of events 78 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Neck pain
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN OVARIAN CYST
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Neuralgia
|
3.3%
1/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
26.7%
8/30 • Number of events 26 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
10.0%
3/30 • Number of events 11 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Oculomotor nerve disorder
|
3.3%
1/30 • Number of events 22 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Olfactory nerve disorder
|
3.3%
1/30 • Number of events 21 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Oral pain
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Ear and labyrinth disorders
Otitis media
|
6.7%
2/30 • Number of events 10 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Pain in extremity
|
16.7%
5/30 • Number of events 37 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Paronychia
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Pelvic pain
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.3%
1/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
6/30 • Number of events 21 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Psychiatric disorders
Personality change
|
3.3%
1/30 • Number of events 17 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Psychiatric disorders
Photophobia
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
73.3%
22/30 • Number of events 155 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Pneumonitis
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Postnasal drip
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.3%
1/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.3%
4/30 • Number of events 13 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Renal and urinary disorders
DECREASED EGFR
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
STENT REMOVAL
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
HIGHTENED SENSE OF SMELL
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
GROUND GLASS APPERANCE
|
3.3%
1/30 • Number of events 5 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus bradycardia
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Sinusitis
|
10.0%
3/30 • Number of events 14 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
HAND - FOOT SYNDROME
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
MULTIPLE BUMPS ON HEAD
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
BRITTLE NAILS
|
3.3%
1/30 • Number of events 6 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
SKIN PEELING ON HANDS
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
2/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Skin infection
|
10.0%
3/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Somnolence
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
General disorders
Sore throat
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Stomach pain
|
3.3%
1/30 • Number of events 2 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
3.3%
1/30 • Number of events 6 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Vascular disorders
Thromboembolic event
|
6.7%
2/30 • Number of events 16 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Tooth infection
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
6/30 • Number of events 13 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
1/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Infections and infestations
Vaginal infection
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Vitreous hemorrhage
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.3%
1/30 • Number of events 3 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
8/30 • Number of events 14 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Eye disorders
Watering eyes
|
3.3%
1/30 • Number of events 1 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Metabolism and nutrition disorders
Weight gain
|
6.7%
2/30 • Number of events 4 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Metabolism and nutrition disorders
Weight loss
|
43.3%
13/30 • Number of events 65 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
43.3%
13/30 • Number of events 78 • From the start of treatment until death from any cause, assessed up to 180 days after the last dose of vorinostat] maximum treatment duration= 24 months
|
Additional Information
Dr. Ulka N. Vaishampayan
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60