Trial Outcomes & Findings for A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU) (NCT NCT00978250)

Last Updated: 2019-12-27

Results Overview

Progression-free survival (PFS) is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

95 participants

Primary outcome timeframe

until subject progressed or went off study for other reasons (up to approximately 1 year)

Results posted on

2019-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Small Cell Lung Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.	Breast Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.	Bladder Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.	Head and Neck Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.
Overall Study STARTED	25	30	18	22
Overall Study COMPLETED	25	29	18	21
Overall Study NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-Small Cell Lung Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.	Breast Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.	Bladder Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.	Head and Neck Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.
Overall Study Late determination of ineligibility	0	1	0	1

Baseline Characteristics

A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Small Cell Lung Cancer Stratum n=25 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.	Breast Cancer Stratum n=30 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.	Bladder Cancer Stratum n=18 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.	Head and Neck Cancer Stratum n=22 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.	Total n=95 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	24 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants	61 Participants n=21 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	6 Participants n=4 Participants	34 Participants n=21 Participants
Age, Continuous	59.92 years STANDARD_DEVIATION 9.95 • n=5 Participants	56.04 years STANDARD_DEVIATION 10.07 • n=7 Participants	67.77 years STANDARD_DEVIATION 8.93 • n=5 Participants	55.17 years STANDARD_DEVIATION 11.70 • n=4 Participants	59.08 years STANDARD_DEVIATION 11.08 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	30 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	45 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants	19 Participants n=4 Participants	50 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	20 Participants n=7 Participants	17 Participants n=5 Participants	20 Participants n=4 Participants	82 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	22 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants	70 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	25 Participants n=5 Participants	30 Participants n=7 Participants	18 Participants n=5 Participants	22 Participants n=4 Participants	95 Participants n=21 Participants

PRIMARY outcome

Timeframe: until subject progressed or went off study for other reasons (up to approximately 1 year)

Population: All 93 patients eligible for the study were assessed for PFS, including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug.

Outcome measures

Outcome measures
Measure	Non-Small Cell Cancer Stratum n=25 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Breast Cancer Stratum n=29 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Bladder Cancer Stratum n=18 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Heand and Neck Cancer Stratum n=21 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.
Progression-free Survival (PFS)	2.3 months Interval 1.6 to 3.9	3.7 months Interval 1.8 to 5.3	3.6 months Interval 1.7 to 8.0	1.7 months Interval 1.7 to 4.5

PRIMARY outcome

Timeframe: until subject progressed or went off study for other reasons (up to approximately 1 year)

Population: All 93 patients eligible for the study were assessed for complete response (CR) or partial response (PR), including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug.

Response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.

Outcome measures

Outcome measures
Measure	Non-Small Cell Cancer Stratum n=25 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Breast Cancer Stratum n=29 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Bladder Cancer Stratum n=18 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Heand and Neck Cancer Stratum n=21 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.
Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd)	0.0 percentage of participants Interval 0.0 to 13.7	6.9 percentage of participants Interval 0.8 to 22.8	5.6 percentage of participants Interval 0.1 to 27.3	0.0 percentage of participants Interval 0.0 to 16.1

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 109 months and 16 days.

Population: Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Non-Small Cell Cancer Stratum n=93 Participants FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Breast Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Bladder Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.	Heand and Neck Cancer Stratum FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0).	91 Participants	—	—	—

Adverse Events

5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)

Serious events: 38 serious events

Other events: 91 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) n=93 participants at risk FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.
Gastrointestinal disorders Abdominal distension	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Abdominal pain	6.5% 6/93 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Acute kidney injury	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Agitation	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Alkaline phosphatase increased	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Blood and lymphatic system disorders Anemia	4.3% 4/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Anorexia	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Anxiety	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Aspiration	1.1% 1/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Cardiac disorders Atrial fibrillation	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Cardiac disorders Cardiac arrest	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Cognitive disturbance	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Colitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Constipation	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Death NOS	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Dehydration	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Diarrhea	4.3% 4/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Duodenal ulcer	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Dysphagia	4.3% 4/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.5% 7/93 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Enterocolitis infectious	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Esophagitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Fatigue	5.4% 5/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Blood and lymphatic system disorders Febrile neutropenia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Fever	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastrointestinal disorders - Other, Diverticulitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Hematuria	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypercalcemia	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypermagnesemia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypoalbuminemia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypokalemia	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hyponatremia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypophosphatemia	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Ileus	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, port infection (right)	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Lung infection	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Lymphocyte count decreased	6.5% 6/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Mucosal infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Mucositis oral	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Multi-organ failure	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Myalgia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Nausea	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Nervous system disorders - Other, Bilateral lower extremity weakness/paraplegia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Neutrophil count decreased	4.3% 4/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Oral hemorrhage	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Platelet count decreased	3.2% 3/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Retinopathy	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Sepsis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Syncope	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Vascular disorders Thromboembolic event	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Upper respiratory infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Urinary retention	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Urinary tract infection	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Injury, poisoning and procedural complications Vascular access complication	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Vomiting	4.3% 4/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Weight loss	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations White blood cell decreased	5.4% 5/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastrointestinal disorders - Other, Pyloric ulcer	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastrointestinal disorders - Other, Partial small bowel obstruction	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, Clostridium difficile	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, Viral syndrome	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.

Other adverse events

Other adverse events
Measure	5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) n=93 participants at risk FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.
Gastrointestinal disorders Abdominal distension	3.2% 3/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Abdominal infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Abdominal pain	21.5% 20/93 • Number of events 34 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Activated partial thromboplastin time prolonged	12.9% 12/93 • Number of events 13 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Agitation	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Alanine aminotransferase increased	36.6% 34/93 • Number of events 83 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Alkaline phosphatase increased	28.0% 26/93 • Number of events 49 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Immune system disorders Allergic reaction	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Alopecia	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Blood and lymphatic system disorders Anemia	66.7% 62/93 • Number of events 196 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Anorexia	39.8% 37/93 • Number of events 65 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Anxiety	6.5% 6/93 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Ascites	1.1% 1/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Aspartate aminotransferase increased	38.7% 36/93 • Number of events 78 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Aspiration	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Back pain	14.0% 13/93 • Number of events 20 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Bloating	5.4% 5/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Adenopathy: supraclavicular node	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Blood bilirubin increased	8.6% 8/93 • Number of events 12 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Blurred vision	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Body odor	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Bone pain	4.3% 4/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Injury, poisoning and procedural complications Bruising	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Buttock pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations CPK increased	4.3% 4/93 • Number of events 10 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Cardiac disorders Cardiac troponin I increased	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Cataract	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Catheter related infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Chest wall pain	2.2% 2/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Chills	14.0% 13/93 • Number of events 18 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Cognitive disturbance	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Confusion	3.2% 3/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Conjunctivitis infective	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Constipation	37.6% 35/93 • Number of events 47 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Cough	20.4% 19/93 • Number of events 30 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Creatinine increased	15.1% 14/93 • Number of events 29 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Dehydration	12.9% 12/93 • Number of events 17 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Delirium	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Depression	2.2% 2/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Diarrhea	38.7% 36/93 • Number of events 81 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Dizziness	12.9% 12/93 • Number of events 13 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Dry eye	2.2% 2/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Dry mouth	8.6% 8/93 • Number of events 10 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Dry skin	8.6% 8/93 • Number of events 11 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Dysarthria	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Dysesthesia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Dysgeusia	9.7% 9/93 • Number of events 10 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Dyspepsia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Dysphagia	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.8% 24/93 • Number of events 37 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Edema face	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Edema limbs	24.7% 23/93 • Number of events 25 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Enterocolitis infectious	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.4% 5/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Erythema multiforme	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Esophageal pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Eye disorders - Other, Non-visibility spots, eye stain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Eye disorders - Other, Visual changes	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Injury, poisoning and procedural complications Fall	4.3% 4/93 • Number of events 8 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Fatigue	66.7% 62/93 • Number of events 188 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Blood and lymphatic system disorders Febrile neutropenia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Fever	24.7% 23/93 • Number of events 53 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Flank pain	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Flatulence	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Flu like symptoms	6.5% 6/93 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Gait disturbance	4.3% 4/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastritis	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastroesophageal reflux disease	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastrointestinal disorders - Other, "pin point" ulcer on tongue	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastrointestinal pain	1.1% 1/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.5% 6/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Reproductive system and breast disorders Genital edema	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Gum infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Headache	14.0% 13/93 • Number of events 16 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Hematuria	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Hemoglobin increased	2.2% 2/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Hemorrhoidal hemorrhage	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Hemorrhoids	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Hepatobiliary disorders Hepatobiliary disorders - Other, Cirrhosis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Hiccups	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Hoarseness	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Vascular disorders Hot flashes	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypercalcemia	18.3% 17/93 • Number of events 31 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hyperglycemia	10.8% 10/93 • Number of events 27 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hyperkalemia	8.6% 8/93 • Number of events 20 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypermagnesemia	9.7% 9/93 • Number of events 12 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypernatremia	4.3% 4/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Vascular disorders Hypertension	31.2% 29/93 • Number of events 175 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hyperuricemia	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypoalbuminemia	65.6% 61/93 • Number of events 174 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypocalcemia	21.5% 20/93 • Number of events 45 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypoglycemia	8.6% 8/93 • Number of events 8 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypokalemia	24.7% 23/93 • Number of events 47 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypomagnesemia	25.8% 24/93 • Number of events 58 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hyponatremia	52.7% 49/93 • Number of events 115 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Metabolism and nutrition disorders Hypophosphatemia	28.0% 26/93 • Number of events 49 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Vascular disorders Hypotension	14.0% 13/93 • Number of events 21 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations INR increased	4.3% 4/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, C. difficile infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Infusion related reaction	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Infusion site extravasation	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Injection site reaction	5.4% 5/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Insomnia	8.6% 8/93 • Number of events 8 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Investigations - Other, Bicarbonate, serum-low	4.3% 4/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Lethargy	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Lip infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Blood and lymphatic system disorders Lymph node pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Vascular disorders Lymphedema	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Lymphocyte count decreased	64.5% 60/93 • Number of events 265 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Malaise	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Memory impairment	2.2% 2/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Mucosal infection	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Mucositis oral	9.7% 9/93 • Number of events 13 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, locking of fingers-middle and ring	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 6/93 • Number of events 7 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Nail discoloration	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Nail infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Nausea	61.3% 57/93 • Number of events 107 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Neck pain	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Nervous system disorders - Other, saddle anesthesia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Neuralgia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Neutrophil count decreased	30.1% 28/93 • Number of events 76 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Oral hemorrhage	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
General disorders Pain	16.1% 15/93 • Number of events 25 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Pain in extremity	12.9% 12/93 • Number of events 18 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	4.3% 4/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Paresthesia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Paronychia	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Reproductive system and breast disorders Pelvic pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Penile infection	1.1% 1/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Cardiac disorders Pericardial effusion	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Peripheral motor neuropathy	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Peripheral sensory neuropathy	8.6% 8/93 • Number of events 14 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Platelet count decreased	39.8% 37/93 • Number of events 91 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.4% 5/93 • Number of events 6 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Productive cough	5.4% 5/93 • Number of events 5 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Proteinuria	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Pruritus	11.8% 11/93 • Number of events 11 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Rash acneiform	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.5% 7/93 • Number of events 12 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Renal and urinary disorders - Other, renal insufficiency	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Renal calculi	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, Orchitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Difficulty breathing	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Psychiatric disorders Restlessness	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Scleral disorder	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Cardiac disorders Sinus bradycardia	1.1% 1/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Cardiac disorders Sinus tachycardia	11.8% 11/93 • Number of events 34 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Sinusitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Blisters	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Folliculitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin hypopigmentation	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Skin infection	2.2% 2/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin ulceration	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Somnolence	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Sore throat	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Stroke	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Vascular disorders Superficial thrombophlebitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Surgical and medical procedures Surgical and medical procedures - Other, hip surgery	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Syncope	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Vascular disorders Thromboembolic event	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Ear and labyrinth disorders Tinnitus	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Tremor	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Trismus	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	3.2% 3/93 • Number of events 3 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Urinary frequency	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Urinary retention	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Urinary tract infection	7.5% 7/93 • Number of events 10 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Urinary tract pain	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Urticaria	1.1% 1/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Vaginal infection	1.1% 1/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Ear and labyrinth disorders Vertigo	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Voice alteration	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Vomiting	29.0% 27/93 • Number of events 38 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Eye disorders Watering eyes	3.2% 3/93 • Number of events 4 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Weight gain	1.1% 1/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations Weight loss	28.0% 26/93 • Number of events 41 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Wheezing	2.2% 2/93 • Number of events 2 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Investigations White blood cell decreased	52.7% 49/93 • Number of events 181 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Wound infection	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Gastrointestinal disorders Gastrointestinal disorders - Other, Blood in stool	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, Herpes	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, Cryptosporidium	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, C. difficile colitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, catheter related	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, Infection with unknown ANC: Blood	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, Swelling - right arm	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, chest tightness	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, hip pain	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Nervous system disorders Nervous system disorders - Other, disk replacement	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Renal and urinary disorders Renal and urinary disorders - Other, urinary output decreased	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, nasal drainage	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, facial erythema	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, scleroderma @ hands and feet	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, nail changes	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, discoloration of leg	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, rash	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Infections and infestations Infections and infestations - Other, Sinusitis	1.1% 1/93 • Number of events 1 • Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.

Additional Information

Dr. James Doroshow

National Cancer Institute

Phone: 240-781-3320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place