Trial Outcomes & Findings for A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer (NCT NCT01356628)

NCT ID: NCT01356628

Last Updated: 2025-07-28

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST Version 1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progression.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
• Results posted on: 2025-07-28

Participant Flow

Participant milestones

Measure	PD-0332991 PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer

Baseline characteristics by cohort

Measure	PD-0332991 n=23 Participants PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST Version 1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progression.

Outcome measures

Measure	PD-0332991 n=23 Participants PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Time to Disease Progression	8 months Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: From date of randomization through study completion, assessed up to 100 months

The number and nature of adverse events as a measure of safety and tolerability. Safety analysis will be conducted on all patients who receive at least one dose of PD-0332991 during the study period or follow-up. An adverse event is any unfavorable and unintended sign, symptom, syndrome or illness that develops during the period of observation in the clinical study, including a new illness or condition, worsening of a concomitant illnesses or condition, effect of the study medication or combination of 2 or more factors.

Outcome measures

Measure	PD-0332991 n=23 Participants PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Number of Adverse Events	504 Adverse Events

SECONDARY outcome

Timeframe: Every 2 weeks during first 3 cycles, then monthly during treatment. Then Day 28, Day 56 and every 3 months from last administration of protocol directed therapy or death

Population: excluding 2 patients who are alive at 137 and 73 weeks.

Overall survival (OS) is measured from the entry onto the trial until death of any cause. Date and cause of death will be recorded. The cause of death will be categorized as either cancer-related or cancer-unrelated.

Outcome measures

Measure	PD-0332991 n=23 Participants PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Overall Survival (OS)	40 weeks Interval 24.0 to 96.0

SECONDARY outcome

Timeframe: Every 8 weeks

Population: 4 patients were non-evaluable

The best overall response is the best response recorded from the start of treatment until disease progression or recurrence. The objective response rate is the proportion of subjects with either a confirmed complete response (CR) or a confirmed partial response (PR) as determined using modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Subjects with the response of stable disease (SD) will be recorded and documented. Disease control rate defined as CR+PR+SD will be calculated for all subjects treated with PD-0332991.

Outcome measures

Measure	PD-0332991 n=19 Participants PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Response Rate (RR) Partial Response (PR)	1 Participants
Response Rate (RR) Complete Response (CR)	0 Participants
Response Rate (RR) Stable Disease (SD)	7 Participants
Response Rate (RR) Progressive Disease	11 Participants

Adverse Events

PD-0332991

Serious events: 11 serious events

Other events: 23 other events

Deaths: 20 deaths

Serious adverse events

Measure	PD-0332991 n=23 participants at risk PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Gastrointestinal disorders Vomiting	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Peritoneal Infection	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Leukopenia	13.0% 3/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Neutropenia	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Lower abdomen pain	13.0% 3/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Musculoskeletal and connective tissue disorders Lower leg weakness	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Nervous system disorders Spinal cord compression	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hyperbilirubinema	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Fever	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypercalcemia	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hyperkalemia	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Anemia	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Thrombocytopenia	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Fracture of left Humorous	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Dehydration	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Psychiatric disorders Confusion	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Ascites	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Diarrhea	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Sepsis	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Hepatobiliary disorders Hepatic Failure	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities

Other adverse events

Measure	PD-0332991 n=23 participants at risk PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma PD-0332991: PD-0332991, 125mg, 3 cycles
Blood and lymphatic system disorders Thrombocytopenia	87.0% 20/23 • Number of events 56 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Alanine Aminotransferase Increased	43.5% 10/23 • Number of events 28 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Alkaline Phosphate Increase	34.8% 8/23 • Number of events 15 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Anemia	56.5% 13/23 • Number of events 23 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Psychiatric disorders Anorexia	30.4% 7/23 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Renal and urinary disorders Ascites	43.5% 10/23 • Number of events 22 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Aspartate Aminotransferase Increased	21.7% 5/23 • Number of events 8 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Blood in Stool	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Eye disorders Blurred Vision	13.0% 3/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Body Aches/Pan	30.4% 7/23 • Number of events 8 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Chills	13.0% 3/23 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Renal and urinary disorders Cirrhosis	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Cold	26.1% 6/23 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Constipation	4.3% 1/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Respiratory, thoracic and mediastinal disorders COPD	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Creatine increase	21.7% 5/23 • Number of events 7 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Metabolism and nutrition disorders Decreased Appetite	8.7% 2/23 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Psychiatric disorders Delirium, Post-Op	8.7% 2/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Psychiatric disorders Depression	17.4% 4/23 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Diabetes	21.7% 5/23 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Diarrhea	21.7% 5/23 • Number of events 10 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Diverticulitis	17.4% 4/23 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Dizzyness	17.4% 4/23 • Number of events 7 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Skin and subcutaneous tissue disorders Dry cracked palms	13.0% 3/23 • Number of events 6 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Nervous system disorders Dysphasia	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Reproductive system and breast disorders Dyspnea	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Edema	43.5% 10/23 • Number of events 13 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Emesis	17.4% 4/23 • Number of events 6 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Epigastric	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Epistaxis	8.7% 2/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Fall	26.1% 6/23 • Number of events 6 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Fatigue	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Fever	8.7% 2/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Fungal Esophageal Infection	13.0% 3/23 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Gas	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Gas reflex	13.0% 3/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders GERD	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders GI Bleeding	26.1% 6/23 • Number of events 7 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Gout	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Heartburn	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Hepatitis C	4.3% 1/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hyperbilirubinema	13.0% 3/23 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypercalemia	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hyperglycemia	21.7% 5/23 • Number of events 8 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hyperkalemia	8.7% 2/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hyperlipidemia	17.4% 4/23 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypermagnesemia	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypertension	8.7% 2/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypoalbuminemia	17.4% 4/23 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hyponatremia	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypocalcemia	17.4% 4/23 • Number of events 6 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypokalemia	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypomagnesemia	17.4% 4/23 • Number of events 10 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypophosphatemia	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Hypotension	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Increase in Creatine	13.0% 3/23 • Number of events 3 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Infection, C.Diff	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Inguinal hernia	13.0% 3/23 • Number of events 8 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Injection Site Reaction	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders INR increased	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Nervous system disorders Insomnia	21.7% 5/23 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Renal and urinary disorders Jaundice	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Musculoskeletal and connective tissue disorders leg pain	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Leukopenia	21.7% 5/23 • Number of events 9 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Lightheadedness	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Low ANC	13.0% 3/23 • Number of events 7 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Lymphocytopenia	8.7% 2/23 • Number of events 5 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Mucositis	17.4% 4/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Musculoskeletal and connective tissue disorders Muscle cramping	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Musculoskeletal and connective tissue disorders Muscle weakness	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Nausea	21.7% 5/23 • Number of events 14 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Musculoskeletal and connective tissue disorders Neck Fracture	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Nervous system disorders Neuropathy	26.1% 6/23 • Number of events 8 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders Neutropenia	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Night Sweats	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Pain	13.0% 3/23 • Number of events 4 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Polymicrobial Bacteremia	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Skin and subcutaneous tissue disorders Pruritus (Itching)	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Skin and subcutaneous tissue disorders Rash	8.7% 2/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Skin and subcutaneous tissue disorders Rash Pustular	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Infections and infestations Sinusitis	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Respiratory, thoracic and mediastinal disorders Sleep Apnea	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Stomach Virus	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Nervous system disorders Taste Alteration	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Surgical and medical procedures Tonsillectomy	4.3% 1/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Renal and urinary disorders Urinary Frequency and burning	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Renal and urinary disorders Urine Discoloration	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Eye disorders Vision Change	4.3% 1/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
General disorders Weakness	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Blood and lymphatic system disorders ANC decreased	4.3% 1/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Skin and subcutaneous tissue disorders Dry Skin	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Metabolism and nutrition disorders Metabolism and nutrition disorder	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm benign	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Musculoskeletal and connective tissue disorders Cramping hands and legs	4.3% 1/23 • Number of events 2 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Gastrointestinal disorders Hemorrhoids	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities
Respiratory, thoracic and mediastinal disorders Emphesyma	4.3% 1/23 • Number of events 1 • The adverse event reporting period for this trial begins when the patient receives the first dose of investigational medication and ends 28 days after the patient receives the last dose of his/her study medication regimen for all non-serious adverse events. All serious adverse events will be followed through safety follow-up visits until resolution or return to baseline condition. adverse medication reactions such as overdose, abuse, withdrawal, sensitivity, or toxicity; unrelated illnesses, worsening of a preexisting illness; Injury, accidents, abnormalities in physiological testing or physical examinations, Laboratory abnormalities

Additional Information

Dr. Avnish Bhatia

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-8874

Email: avnish.Bhatia@jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place