Trial Outcomes & Findings for Vorinostat in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma (NCT NCT00253630)

Last Updated: 2018-03-06

Results Overview

Radiological assessment by CT and/or PET scan after every three cycles (every 3 months). Response assessed by the standard Cheson criteria (Cheson et al, J Clin Oncol 17:1244, 1999). Complete Remission (CR) - (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT; Partial Remission (PR) - 50% or greater decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. Response Rate = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2018-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Vorinostat) Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
Overall Study STARTED	37
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Vorinostat) Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
Overall Study ineligible	2

Baseline Characteristics

Vorinostat in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Vorinostat) n=35 Participants Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
Age, Continuous	64.5 years n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Region of Enrollment United States	35 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat) n=35 Participants Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
Response Rate	29 percentage of participants Interval 15.0 to 46.0

PRIMARY outcome

Timeframe: Up to 3 years

Grades 3 \& 4 adverse events definitely, probably or possibly related to treatment, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat) n=35 Participants Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
Number of Participants With Adverse Events ANC	6 Participants
Number of Participants With Adverse Events Anorexia	1 Participants
Number of Participants With Adverse Events Fatigue	3 Participants
Number of Participants With Adverse Events Hemoglobin	4 Participants
Number of Participants With Adverse Events Hypokalemia	1 Participants
Number of Participants With Adverse Events Hyponatremia	1 Participants
Number of Participants With Adverse Events Hypophosphatemia	2 Participants
Number of Participants With Adverse Events Infection -Skin (cellulitis)	1 Participants
Number of Participants With Adverse Events INR	2 Participants
Number of Participants With Adverse Events Leukocytes (total WBC)	4 Participants
Number of Participants With Adverse Events Lymphopenia	5 Participants
Number of Participants With Adverse Events Myalgia	1 Participants
Number of Participants With Adverse Events Mucositis/stomatitis	1 Participants
Number of Participants With Adverse Events Platelets	10 Participants
Number of Participants With Adverse Events Thrombosis/thrombus/embolism	2 Participants

SECONDARY outcome

Timeframe: Baseline to up to day 14

Population: Immunohistochemistry data was not collected and is not available for analysis.

Histone acetylation by IHC will be scored as -, +, ++, or +++, reflecting both the intensity of staining as well as the number of cells stained. Analysis will be descriptive, with the goal of describing baseline distributions and estimating the frequency and degree of changes from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to day 14

Population: Western Blot data was not collected and is not available for analysis.

Histone acetylation by WB will be recorded as the ratio of acetylated histone (measured by photodensitometry) divided by the total histone (H3 or H4), in order to control for the amount of protein loaded. Analysis will be descriptive, with the goal of describing baseline distributions and estimating the frequency and degree of changes from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until Death from any cause, up to 2 years

Estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat) n=35 Participants Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
2-Year Overall Survival	77 percentage of participants Interval 64.0 to 92.0

SECONDARY outcome

Timeframe: Until death or progression, up to 2 years

Estimated using the product-limit method of Kaplan and Meier. Progression defined as any new lesion or increase by greater than 50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Treatment (Vorinostat) n=35 Participants Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
2-Year Progression Free-Survival	37 percentage of participants Interval 24.0 to 57.0

Adverse Events

Treatment (Vorinostat)

Serious events: 9 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Vorinostat) n=35 participants at risk Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
Blood and lymphatic system disorders Hemoglobin decreased	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	5.7% 2/35 • Number of events 2 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	8.6% 3/35 • Number of events 3 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	5.7% 2/35 • Number of events 2 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	2.9% 1/35 • Number of events 1 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Treatment (Vorinostat) n=35 participants at risk Patients receive vorinostat PO BID on days 1-14. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
Gastrointestinal disorders Abdominal distension	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	22.9% 8/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Acne	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Agitation	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	20.0% 7/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	25.7% 9/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	71.4% 25/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ascites	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	40.0% 14/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrioventricular block first degree	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	28.6% 10/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin increased	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bladder infection	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	31.4% 11/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorder	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac valve disease	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Cataract	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Cheilitis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	25.7% 9/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Coagulopathy	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	37.1% 13/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	31.4% 11/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	57.1% 20/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Depressed level of consciousness	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	85.7% 30/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Diplopia	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	45.7% 16/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye syndrome	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	28.6% 10/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	25.7% 9/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	40.0% 14/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	37.1% 13/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	37.1% 13/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Erectile dysfunction	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders External ear pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Extrapyramidal disorder	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorder	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	97.1% 34/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	14.3% 5/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu-like symptoms	40.0% 14/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Gait abnormal	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Glomerular filtration rate decreased	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	34.3% 12/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hematoma	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	85.7% 30/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemolysis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hemorrhage	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	17.1% 6/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hemorrhage urinary tract	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercholesterolemia	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	28.6% 10/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Hypersensitivity	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperuricemia	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 14/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	20.0% 7/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	20.0% 7/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	22.9% 8/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	14.3% 5/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	14.3% 5/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Intra-abdominal hemorrhage	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint disorder	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	20.0% 7/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Kidney pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Laboratory test abnormal	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	40.0% 14/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	25.7% 9/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Lip infection	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	22.9% 8/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	17.1% 6/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	20.0% 7/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	17.1% 6/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	37.1% 13/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail disorder	14.3% 5/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	74.3% 26/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Neck pain	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neurological disorder NOS	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	48.6% 17/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral hemorrhage	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	22.9% 8/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	25.7% 9/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Pelvic pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Periodontal disease	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	22.9% 8/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Petechiae	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal stenosis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pharyngitis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	17.1% 6/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	85.7% 30/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Proctoscopy abnormal	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Protein urine positive	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash acneiform	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	20.0% 7/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Reproductive tract disorder	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	20.0% 7/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Rhinitis infective	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	37.1% 13/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	17.1% 6/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium increased	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Serum cholesterol increased	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	22.9% 8/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium decreased	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium increased	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	45.7% 16/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	14.3% 5/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium increased	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	25.7% 9/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium increased	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum triglycerides increased	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin disorder	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin induration	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin ulceration	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Small intestinal mucositis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	31.4% 11/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	42.9% 15/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tremor	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	5.7% 2/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal hemorrhage	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal inflammation	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal pain	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Vascular disorder	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	8.6% 3/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	37.1% 13/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Vulvitis	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	11.4% 4/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	34.3% 12/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Wound dehiscence	2.9% 1/35 • All adverse events were collected over a period of 10 years, 8 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60