Trial Outcomes & Findings for BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients (NCT NCT02650804)

NCT ID: NCT02650804

Last Updated: 2025-03-26

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. (the appearance of new lesions is also considered progression); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 10 weeks (End of Cycle 2)
• Results posted on: 2025-03-26

Participant Flow

Participant milestones

Measure	BPM31510 Monotherapy BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).	BPM31510 Plus Gemcitabine BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine
Overall Study STARTED	17	28
Overall Study Completed First 2 Cycles	3	16
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	17	28

Reasons for withdrawal

Measure	BPM31510 Monotherapy BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).	BPM31510 Plus Gemcitabine BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine
Overall Study Adverse Event	3	2
Overall Study Death	1	2
Overall Study Progressive Disease	7	10
Overall Study Physician Decision	0	2
Overall Study Withdrawal by Subject	1	4
Overall Study Symptomatic deterioration	5	7
Overall Study Protocol Violation	0	1

Baseline Characteristics

BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients

Baseline characteristics by cohort

Measure	BPM31510 Monotherapy n=17 Participants BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).	BPM31510 Plus Gemcitabine n=28 Participants BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine	Total n=45 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 10.9 • n=5 Participants	64.1 years STANDARD_DEVIATION 9.5 • n=7 Participants	63.3 years STANDARD_DEVIATION 10.0 • n=5 Participants
Age, Customized < 60 years	7 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Age, Customized 60 - 69 years	4 participants n=5 Participants	16 participants n=7 Participants	21 participants n=5 Participants
Age, Customized >= 70 years	6 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	24 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	25 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks (End of Cycle 2)

Population: Adequately Treated Analysis Set (ATAS) - defined as all the patients who met the inclusion/exclusion criteria, completed at least the first two cycles of therapy with a total of at least 18 days of drug infusion during Cycle 1 and at least 12 days of drug infusion during Cycle 2, and had an initial evaluation of response following the end of the second cycle such that an overall response was considered evaluable based on RECIST 1.1 criteria.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. (the appearance of new lesions is also considered progression); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR

Outcome measures

Measure	BPM31510 Monotherapy n=3 Participants BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).	BPM31510 Plus Gemcitabine n=16 Participants BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine
Treatment Response Stable disease	1 participants	8 participants
Treatment Response Complete Response	0 participants	0 participants
Treatment Response Partial Response	0 participants	0 participants
Treatment Response Progressive Disease	2 participants	8 participants
Treatment Response Overall Response	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to study completion, an average of 1 year

Population: Adequately Treated Analysis Set (ATAS) - defined as all the patients who met the inclusion/exclusion criteria, completed at least the first two cycles of therapy with a total of at least 18 days of drug infusion during Cycle 1 and at least 12 days of drug infusion during Cycle 2, and had an initial evaluation of response following the end of the second cycle such that an overall response was considered evaluable based on RECIST 1.1 criteria.

Overall Survival is defined as the number of months from the first dose of study drug to the date of death due to any cause.

Outcome measures

Measure	BPM31510 Monotherapy n=3 Participants BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).	BPM31510 Plus Gemcitabine n=16 Participants BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine
Overall Survival (OS)	7.4 Months Interval 4.4 to 9.5	7.3 Months Interval 4.7 to 8.7

SECONDARY outcome

Timeframe: Day 1, End of Cycle 2 (10 weeks) and every 2 cycles (every 8 weeks) through study completion, an average of 1 year

Population: Adequately Treated Analysis Set (ATAS) - defined as all the patients who met the inclusion/exclusion criteria, completed at least the first two cycles of therapy with a total of at least 18 days of drug infusion during Cycle 1 and at least 12 days of drug infusion during Cycle 2, and had an initial evaluation of response following the end of the second cycle such that an overall response was considered evaluable based on RECIST 1.1 criteria.

Time to Progression is defined as tumor progression measured from the first dose of study drug to the first documentation of progression.

Outcome measures

Measure	BPM31510 Monotherapy n=3 Participants BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).	BPM31510 Plus Gemcitabine n=16 Participants BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine
Time to Progression (TTP)	2.4 Months Interval 2.3 to 4.4	4.0 Months Interval 2.3 to 4.8

SECONDARY outcome

Timeframe: Up to study completion, an average of 1 year

Population: PFS is defined as the number of months from the first dose of study drug to the first documentation of progression or death due to any cause.

The number of months from the first dose of study drug to the first documentation of progression or death due to any cause.

Outcome measures

Measure	BPM31510 Monotherapy n=3 Participants BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).	BPM31510 Plus Gemcitabine n=16 Participants BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine
Progression Free Survival (PFS)	2.4 Months Interval 2.3 to 4.4	4.0 Months Interval 2.3 to 4.4

Adverse Events

BPM31510 Plus Gemcitabine

Serious events: 12 serious events

Other events: 28 other events

Deaths: 28 deaths

BPM31510 Monotherapy

Serious events: 10 serious events

Other events: 16 other events

Deaths: 17 deaths

Serious adverse events

Measure	BPM31510 Plus Gemcitabine n=28 participants at risk BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine	BPM31510 Monotherapy n=17 participants at risk BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).
Blood and lymphatic system disorders Anaemia	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Blood and lymphatic system disorders Disseminated intravascular coagulation.	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Blood and lymphatic system disorders Thrombocytopenia	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Cardiac disorders Acute myocardial infarction	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Abdominal distension	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Abdominal pain	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	29.4% 5/17 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Ascites	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Duodenal obstruction	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Erosive oesophagitis	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Gastric haemorrhage	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Nausea	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Vomiting	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Hepatobiliary disorders Cholangitis	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Hepatobiliary disorders Hepatic failure	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Bacterial sepsis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Pneumonia	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Sepsis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Septic shock	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Injury, poisoning and procedural complications Fall	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations International normalised ratio increased	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hypoglycaemia	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Cerebrovascular accident	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Encephalopathy	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Seizure	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.

Other adverse events

Measure	BPM31510 Plus Gemcitabine n=28 participants at risk BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2. Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks and gemcitabine administered on Mondays, Days 7, 14 and 21. BPM31510 Nanosuspension Injection Gemcitabine	BPM31510 Monotherapy n=17 participants at risk BPM31510 IV nanosuspension injection (40mg/mL) was administered over 144 hours (two 72-hour 110 mg/Kg doses per week). Each patient received 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).
Blood and lymphatic system disorders Anaemia	39.3% 11/28 • Number of events 11 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	23.5% 4/17 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Blood and lymphatic system disorders Neutropenia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 7/28 • Number of events 7 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Cardiac disorders Cardiomegaly	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Eye disorders Vision blurred	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Abdominal distension	14.3% 4/28 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	17.6% 3/17 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Abdominal pain	25.0% 7/28 • Number of events 7 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	35.3% 6/17 • Number of events 6 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Abdominal pain upper	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Ascites	21.4% 6/28 • Number of events 6 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Constipation	25.0% 7/28 • Number of events 7 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	29.4% 5/17 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Diarrhoea	17.9% 5/28 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Haemorrhoids	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Lip ulceration	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Nausea	35.7% 10/28 • Number of events 10 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	29.4% 5/17 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Gastrointestinal disorders Vomiting	25.0% 7/28 • Number of events 7 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	47.1% 8/17 • Number of events 8 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Asthenia	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Catheter site erythema	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Catheter site extravasation	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Catheter site haemorrhage	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Catheter site pain	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Chills	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Early satiety	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Fatigue	57.1% 16/28 • Number of events 16 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	58.8% 10/17 • Number of events 10 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Malaise	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Oedema peripheral	17.9% 5/28 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	17.6% 3/17 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
General disorders Pyrexia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Hepatobiliary disorders Hyperbilirubinaemia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Hepatobiliary disorders Jaundice	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Hepatobiliary disorders Ocular icterus	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Cellulitis	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Gastroenteritis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Liver abscess	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Oral candidiasis	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Oral herpes	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Pneumonia	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Upper respiratory tract infection	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Infections and infestations Urinary tract infection	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Injury, poisoning and procedural complications Contusion	14.3% 4/28 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Injury, poisoning and procedural complications Fall	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Injury, poisoning and procedural complications Skin abrasion	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Activated partial thromboplastin time prolonged	17.9% 5/28 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Alanine aminotransferase increased	25.0% 7/28 • Number of events 7 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Aspartate aminotransferase increased	21.4% 6/28 • Number of events 6 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	23.5% 4/17 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Blood alkaline phosphatase increased	14.3% 4/28 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Blood bilirubin increased	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	23.5% 4/17 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Blood lactate dehydrogenase increased	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations C-reactive protein increased	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Coronavirus test positive	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Fibrin d dimer increased	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Gamma-glutamyltransferase increased	17.9% 5/28 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations International normalised ratio	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations International normalised ratio increased	64.3% 18/28 • Number of events 18 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	41.2% 7/17 • Number of events 7 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Liver function test increased	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Lymphocyte count decreased	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Neutrophil count decreased	32.1% 9/28 • Number of events 9 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Platelet count decreased	42.9% 12/28 • Number of events 12 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Prothrombin time prolonged	21.4% 6/28 • Number of events 6 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations Weight decreased	25.0% 7/28 • Number of events 7 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Investigations White blood cell count decreased	17.9% 5/28 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Decreased appetite	32.1% 9/28 • Number of events 9 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	23.5% 4/17 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Dehydration	17.9% 5/28 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	23.5% 4/17 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hypoalbuminaemia	14.3% 4/28 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hypoglycaemia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hypokalaemia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hypomagnesaemia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hyponatraemia	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Metabolism and nutrition disorders Hypophosphataemia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Musculoskeletal and connective tissue disorders Arthralgia	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Musculoskeletal and connective tissue disorders Back pain	14.3% 4/28 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	23.5% 4/17 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Dizziness	14.3% 4/28 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Dysaesthesia	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Encephalopathy	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Lethargy	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Memory impairment	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Nervous system disorders Somnolence	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Product Issues Needle issue	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Psychiatric disorders Anxiety	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Psychiatric disorders Confusional state	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Psychiatric disorders Hallucination	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Psychiatric disorders Insomnia	3.6% 1/28 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Renal and urinary disorders Acute kidney injury	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Renal and urinary disorders Chromaturia	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Psychiatric disorders Proteinuria	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Reproductive system and breast disorders Reproductive system and breast disorders	10.7% 3/28 • Number of events 4 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.9% 5/28 • Number of events 5 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	17.6% 3/17 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	11.8% 2/17 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Skin and subcutaneous tissue disorders Pruritus	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Skin and subcutaneous tissue disorders Rash	7.1% 2/28 • Number of events 2 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	0.00% 0/17 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Vascular disorders Deep vein thrombosis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Vascular disorders Hot flush	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Vascular disorders Hypertension	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	17.6% 3/17 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Vascular disorders Hypotension	10.7% 3/28 • Number of events 3 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Vascular disorders Orthostatic hypotension	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.
Vascular disorders Vena cava thrombosis	0.00% 0/28 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.	5.9% 1/17 • Number of events 1 • Adverse event data were collected for one (1) year. (approximately 12 cycles) Patients could continue treatment for up to 12 cycles in the absence of progressive disease, unacceptable toxicity, or until any of the discontinuation criteria were met..Patients evaluated as having gemcitabine toxicity or disease progression could remain on monotherapy at the Investigator's discretion, if they experienced clinical benefit, and after consultation with the Sponsor. Safety assessments were based on AEs and serious adverse events (SAEs), hematology, coagulation (PT, PTT, and INR), clinical chemistry, urinalysis variables, vital signs, and other protocol-specified tests that were deemed critical to the safety evaluation of the trial drug. Selected laboratory measurements were graded using CTCAE criteria. Toxicity grading was defined using CTCAE v4.02.

Additional Information

Head of Clinical Operations

BPGbio Inc

Phone: 6175880083

Email: clinicaltrials.connect@berghealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release regarding trial results.
• Publication restrictions are in place

Restriction type: OTHER