Trial Outcomes & Findings for Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (NCT NCT01482962)

NCT ID: NCT01482962

Last Updated: 2018-07-31

Results Overview

ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 271 participants
• Primary outcome timeframe: Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
• Results posted on: 2018-07-31

Participant Flow

Participants took part in the study at 105 investigative sites in the United States including Puerto Rico, Canada, European Union, Russian Federation, Turkey, Israel, Australia, New Zealand and Latin America from 11 June 2012 to the end of study on 18 December 2017.

Participants with a diagnosis of Relapsed or Refractory Peripheral T-Cell Lymphoma were randomized 1:1 to either alisertib or comparator (investigator's choice of pralatrexate, romidepsin [USA only], or gemcitabine).

Participant milestones

Measure	Alisertib Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Overall Study STARTED	138	133
Overall Study Safety Population: Received Study Drug	137	127
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	138	133

Reasons for withdrawal

Measure	Alisertib Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Overall Study Progressive Disease	65	53
Overall Study Unsatisfactory Therapeutic Response	37	23
Overall Study Adverse Event	18	22
Overall Study Withdrawal by Participant	8	13
Overall Study Hematopoietic Stem Cell Transplant	3	9
Overall Study Other Reason	1	5
Overall Study Study Terminated by Sponsor	5	2
Overall Study Did not Receive Study Drug	1	6

Baseline Characteristics

Body surface area (m^2)=square root [height (cm)*weight (kg)/3600].

Baseline characteristics by cohort

Measure	Alisertib n=138 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=133 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).	Total n=271 Participants Total of all reporting groups
Age, Continuous	61.1 years STANDARD_DEVIATION 12.69 • n=5 Participants	61.4 years STANDARD_DEVIATION 13.16 • n=7 Participants	61.3 years STANDARD_DEVIATION 12.90 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	86 Participants n=7 Participants	178 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants	107 Participants n=7 Participants	212 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White	115 participants n=5 Participants	114 participants n=7 Participants	229 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Other	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Not Reported	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Australia	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Austria	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Belgium	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Brazil	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Bulgaria	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Czech Republic	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Denmark	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment France	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Germany	6 participants n=5 Participants	1 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Hungary	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Israel	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Italy	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Mexico	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment New Zealand	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Peru	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Poland	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Portugal	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Puerto Rico	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Romania	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Russia	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Spain	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Sweden	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Turkey	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants	8 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	39 participants n=7 Participants	68 participants n=5 Participants
Height	170.3 cm STANDARD_DEVIATION 9.80 • n=5 Participants	168.2 cm STANDARD_DEVIATION 8.99 • n=7 Participants	169.3 cm STANDARD_DEVIATION 9.45 • n=5 Participants
Weight	76.85 kg STANDARD_DEVIATION 17.242 • n=5 Participants	74.63 kg STANDARD_DEVIATION 19.601 • n=7 Participants	75.76 kg STANDARD_DEVIATION 18.437 • n=5 Participants
Body Surface Area (BSA)	1.897 m^2 STANDARD_DEVIATION 0.2465 • n=5 Participants • Body surface area (m\^2)=square root \[height (cm)\*weight (kg)/3600\].	1.855 m^2 STANDARD_DEVIATION 0.2562 • n=7 Participants • Body surface area (m\^2)=square root \[height (cm)\*weight (kg)/3600\].	1.877 m^2 STANDARD_DEVIATION 0.2517 • n=5 Participants • Body surface area (m\^2)=square root \[height (cm)\*weight (kg)/3600\].

PRIMARY outcome

Timeframe: Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Population: Response-evaluable population, participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at Baseline, who received at least 1 dose of alisertib or comparator and had postbaseline response assessment of CR, PR, stable disease (SD) or progressive disease (PD) by the IRC.

ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.

Outcome measures

Measure	Alisertib n=102 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=92 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment	33 percentage of participants Interval 24.0 to 43.0	45 percentage of participants Interval 34.0 to 55.0

PRIMARY outcome

Timeframe: Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Population: Intent-to-treat (ITT) population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.

PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first.

Outcome measures

Measure	Alisertib n=138 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=133 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Progression-Free Survival (PFS) Based on IRC Assessment	115 days Interval 83.0 to 174.0	104 days Interval 61.0 to 114.0

SECONDARY outcome

Timeframe: Participants were followed for survival for 2 years from date of last participant off study treatment, or death, whichever occurs first. Contacts were every 4 months (Median follow-up 519 days in the alisertib arm and 586 days in the comparative arm)

Population: ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.

OS was defined as the time from the date of randomization to the date of death. Participants without documentation of death were censored at the date last known to be alive.

Outcome measures

Measure	Alisertib n=138 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=133 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Overall Survival (OS)	415 days Interval 263.0 to 514.0	367 days Interval 258.0 to 572.0

SECONDARY outcome

Timeframe: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)

Population: Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/ birth defect or is a medically important event.

Outcome measures

Measure	Alisertib n=137 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=127 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	136 participants	126 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	75 participants	69 participants

SECONDARY outcome

Timeframe: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)

Population: Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.

Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.

Outcome measures

Measure	Alisertib n=137 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=127 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Neutrophil Count Decreased	18 participants	14 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs White Blood Cell Count Decreased	17 participants	10 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Lymphocyte Count Decreased	6 participants	5 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Monocyte Count Decreased	2 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Lymphocyte Count Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Monocyte Count Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs White Blood Cell Count Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Platelet Count Decreased	15 participants	22 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Alanine Aminotransferase Increased	8 participants	11 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Aspartate Aminotransferase Increased	5 participants	11 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Gamma-glutamyltransferase Increased	6 participants	3 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Bilirubin Increased	2 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Hepatic Enzyme Increased	2 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Liver Function Test Abnormal	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Transaminases Increased	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Alkaline Phosphatase Increased	9 participants	7 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Lactate Dehydrogenase Increased	5 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Creatinine Increased	3 participants	7 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Creatinine Decreased	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Urea Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Potassium Decreased	1 participants	4 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Magnesium Decreased	1 participants	2 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Bicarbonate Decreased	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Calcium Decreased	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Calcium Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Phosphorus Decreased	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Calcium Ionised Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Haemoglobin Decreased	1 participants	3 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Haematocrit Increased	1 participants	2 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Haematocrit Decreased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Coagulation Factor XIII Level Decreased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs International Normalised Ratio Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Albumin Decreased	0 participants	2 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Myocardial Necrosis Marker Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Troponin Increased	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Glucose Increased	0 participants	1 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Immunoglobulins Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Blood Uric Acid Increased	1 participants	0 participants
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs Enterovirus Test Positive	0 participants	1 participants

SECONDARY outcome

Timeframe: First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)

Population: Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.

Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.

Outcome measures

Measure	Alisertib n=137 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=127 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs Heart Rate Increased	1 participants	0 participants
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs Body Temperature Increased	0 participants	1 participants
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs Hypotension	4 participants	6 participants
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs Orthostatic Hypotension	2 participants	1 participants
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs Hypertension	5 participants	7 participants
Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs Pyrexia	48 participants	40 participants

SECONDARY outcome

Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until PD (approximately 3 years)

Population: Response-evaluable population was defined as participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at baseline, who receive at least 1 dose of alisertib or the comparator drug, and 1 postbaseline response assessment of CR, PR, SD or PD by the independent radiology committee.

Complete Response (CR) rate is defined as the percentage of participants with CR as assessed by the IRC using IWG criteria (2007 Cheson). CR= Disappearance of all evidence of disease.

Outcome measures

Measure	Alisertib n=102 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=92 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Complete Response (CR) Rate	18 percentage of participants Interval 11.0 to 26.0	27 percentage of participants Interval 18.0 to 37.0

SECONDARY outcome

Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Population: ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.

Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse.

Outcome measures

Measure	Alisertib n=138 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=133 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Time to Disease Progression (TTP)	162 days Interval 114.0 to 231.0	116 days Interval 101.0 to 227.0

SECONDARY outcome

Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Population: All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.

DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better.

Outcome measures

Measure	Alisertib n=34 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=41 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Duration of Response (DOR)	225 days Interval 125.0 to Upper Limit Confidence Interval was not estimable due to the insufficient number of participants with the event.	172 days Interval 119.0 to Upper Limit Confidence Interval was not estimable due to the insufficient number of participants with the event.

SECONDARY outcome

Timeframe: At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years

Population: All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.

Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better.

Outcome measures

Measure	Alisertib n=34 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=41 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Time to Response	62 days Interval 57.0 to 67.0	64 days Interval 60.0 to 71.0

SECONDARY outcome

Timeframe: From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years

Population: ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.

Time to subsequent antineoplastic therapy was defined as the time from randomization to the first date of subsequent antineoplastic therapy (excluding transplant). Participants without subsequent antineoplastic therapy were censored at the date of death or last known to be alive.

Outcome measures

Measure	Alisertib n=138 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=133 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Time to Subsequent Antineoplastic Therapy	336 days Interval 201.0 to 490.0	233 days Interval 144.0 to 429.0

SECONDARY outcome

Timeframe: Cycle 1, Days 1 and 7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration is approximately 4 months.

Population: This Outcome Measure was registered in error and is not a Primary or Secondary Outcome Measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and End of Treatment (EOT) (Up to 152 Weeks)

Population: ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.

The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better well-being and a positive change from Baseline indicates improvement.

Outcome measures

Measure	Alisertib n=138 Participants Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Pralatrexate, or Romidepsin, or Gemcitabine n=133 Participants Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms Physical Well-Being, EOT	-2.4 score on a scale Standard Deviation 6.21	-1.3 score on a scale Standard Deviation 5.27
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms Social/Family Well-Being, EOT	-0.3 score on a scale Standard Deviation 4.50	0.0 score on a scale Standard Deviation 4.44
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms Emotional Well-Being, EOT	-1.4 score on a scale Standard Deviation 4.59	-0.8 score on a scale Standard Deviation 3.93
Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms Functional Well-Being, EOT	-2.4 score on a scale Standard Deviation 5.40	-0.3 score on a scale Standard Deviation 4.79

Adverse Events

Alisertib

Serious events: 75 serious events

Other events: 134 other events

Deaths: 11 deaths

Gemcitabine

Serious events: 18 serious events

Other events: 29 other events

Deaths: 5 deaths

Pralatrexate

Serious events: 46 serious events

Other events: 72 other events

Deaths: 8 deaths

Romidepsin

Serious events: 6 serious events

Other events: 21 other events

Deaths: 2 deaths

Serious adverse events

Measure	Alisertib n=137 participants at risk Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Gemcitabine n=29 participants at risk Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks).	Pralatrexate n=76 participants at risk Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks).	Romidepsin n=22 participants at risk Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Infections and infestations Pneumonia	6.6% 9/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Lung infection	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Lower respiratory tract infection	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Sepsis	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Septic shock	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Skin infection	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Dermatitis infected	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Upper respiratory tract infection	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Epiglottitis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Tonsillitis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Cytomegalovirus infection	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Cytomegalovirus chorioretinitis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Cellulitis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Pneumonia bacterial	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Clostridium difficile colitis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Clostridium difficile infection	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Respiratory tract infection	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Wound infection	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Pseudomonal sepsis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Erysipelas	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Gastroenteritis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Meningitis aseptic	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Oral infection	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Pneumonia haemophilus	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Eczema herpeticum	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Staphylococcal sepsis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Urinary tract infection	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Febrile neutropenia	17.5% 24/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Neutropenia	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Thrombocytopenia	5.1% 7/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Anaemia	5.1% 7/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Pancytopenia	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Leukopenia	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Pyrexia	8.8% 12/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	20.7% 6/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders General physical health deterioration	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Multiple organ dysfunction syndrome	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Influenza like illness	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Fatigue	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Hypothermia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Catheter site phlebitis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Oedema peripheral	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Pain	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Adverse drug reaction	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Stomatitis	5.1% 7/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	14.5% 11/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Diarrhoea	4.4% 6/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Abdominal pain	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Nausea	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Vomiting	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Intestinal perforation	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Jejunal perforation	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Pancreatitis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Dysphagia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Ileus	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Haematemesis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Ascites	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Cough	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Hiccups	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-cell lymphoma unspecified	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma T- and null-cell types	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Cardiac failure	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Cardiac failure congestive	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Cardiopulmonary failure	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Atrial fibrillation	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Sinus tachycardia	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Bradycardia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Tachycardia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Atrioventricular block second degree	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Cardiomegaly	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Pericarditis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Dehydration	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Hypophagia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Electrolyte imbalance	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Hyperglycaemia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Hypokalaemia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Hypoalbuminaemia	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Cerebrovascular accident	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Haemorrhage intracranial	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Syncope	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Carotid artery aneurysm	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Hepatic encephalopathy	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Facial paralysis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Presyncope	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Renal and urinary disorders Acute kidney injury	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Renal and urinary disorders Acute prerenal failure	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Renal and urinary disorders Renal failure	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Renal and urinary disorders Hydronephrosis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Hepatobiliary disorders Drug-induced liver injury	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Hepatobiliary disorders Cholangitis acute	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Hepatobiliary disorders Cholestasis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Hepatobiliary disorders Hepatic failure	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Hepatobiliary disorders Venoocclusive liver disease	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Rash	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Pain of skin	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Acute generalised exanthematous pustulosis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Back pain	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Vascular disorders Shock haemorrhagic	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Vascular disorders Thrombosis	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Vascular disorders Deep vein thrombosis	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Vascular disorders Orthostatic hypotension	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Immune system disorders Hypersensitivity	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Immune system disorders Anaphylactoid reaction	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Injury, poisoning and procedural complications Fall	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Injury, poisoning and procedural complications Contusion	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Injury, poisoning and procedural complications Spinal compression fracture	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Lymphocyte count decreased	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations White blood cell count decreased	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Blood lactate dehydrogenase increased	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Ear and labyrinth disorders Vertigo	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Staphylococcal skin infection	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adult T-cell lymphoma/leukaemia	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.

Other adverse events

Measure	Alisertib n=137 participants at risk Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).	Gemcitabine n=29 participants at risk Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks).	Pralatrexate n=76 participants at risk Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks).	Romidepsin n=22 participants at risk Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Infections and infestations Conjunctivitis	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.2% 7/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Diarrhoea	44.5% 61/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	17.2% 5/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	23.7% 18/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	45.5% 10/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Stomatitis	30.7% 42/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	63.2% 48/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Nausea	25.5% 35/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	24.1% 7/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	30.3% 23/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	68.2% 15/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Constipation	12.4% 17/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	20.7% 6/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	26.3% 20/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.6% 3/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Vomiting	13.1% 18/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.3% 3/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	19.7% 15/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	18.2% 4/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Abdominal pain	11.7% 16/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.2% 7/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Dyspepsia	8.8% 12/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Abdominal pain upper	5.8% 8/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Mouth ulceration	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Gastrointestinal disorders Odynophagia	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Anaemia	54.0% 74/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	24.1% 7/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	39.5% 30/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	27.3% 6/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Neutropenia	48.2% 66/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	37.9% 11/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	27.6% 21/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	31.8% 7/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Thrombocytopenia	37.2% 51/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	41.4% 12/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	38.2% 29/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	31.8% 7/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Leukopenia	28.5% 39/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	20.7% 6/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Lymphopenia	10.2% 14/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Febrile neutropenia	5.1% 7/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Blood and lymphatic system disorders Lymph node pain	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Fatigue	35.8% 49/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	37.9% 11/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	18.4% 14/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	27.3% 6/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Pyrexia	30.7% 42/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	24.1% 7/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	26.3% 20/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.6% 3/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Oedema peripheral	15.3% 21/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	17.2% 5/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.2% 10/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	22.7% 5/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Asthenia	17.5% 24/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.2% 10/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Chills	6.6% 9/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Malaise	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.3% 3/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Mucosal inflammation	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Peripheral swelling	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
General disorders Chest discomfort	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Platelet count decreased	11.7% 16/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	37.9% 11/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	22.7% 5/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Neutrophil count decreased	13.1% 18/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	17.2% 5/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	18.2% 4/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations White blood cell count decreased	11.7% 16/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	17.2% 5/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Alanine aminotransferase increased	5.8% 8/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	11.8% 9/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Weight decreased	8.8% 12/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Aspartate aminotransferase increased	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.3% 3/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.5% 8/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Blood alkaline phosphatase increased	6.6% 9/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Blood creatinine increased	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.3% 3/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Investigations Haemoglobin decreased	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Alopecia	31.4% 43/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Pruritus	13.9% 19/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	14.5% 11/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	22.7% 5/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Rash	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.2% 7/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Night sweats	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Skin lesion	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Skin and subcutaneous tissue disorders Skin ulcer	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Cough	10.2% 14/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.8% 4/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	22.4% 17/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.6% 3/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.8% 12/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.8% 4/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.5% 8/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	18.2% 4/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	14.5% 11/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.4% 6/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Productive cough	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.73% 1/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Upper respiratory tract infection	10.2% 14/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.3% 3/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Influenza	5.8% 8/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Pneumonia	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Sinusitis	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.6% 3/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Viral upper respiratory tract infection	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Skin infection	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Bronchitis	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Pharyngitis	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Oral herpes	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.3% 3/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Infections and infestations Mucosal infection	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Decreased appetite	19.7% 27/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	18.4% 14/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	40.9% 9/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Hypokalaemia	9.5% 13/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Hypomagnesaemia	6.6% 9/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Dehydration	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.2% 7/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Metabolism and nutrition disorders Hyponatraemia	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Dizziness	11.7% 16/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Headache	10.9% 15/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.6% 5/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Somnolence	10.9% 15/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Dysgeusia	2.2% 3/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	18.2% 4/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Nervous system disorders Disturbance in attention	1.5% 2/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Pain in extremity	10.9% 15/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	10.3% 3/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Back pain	8.8% 12/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	7.9% 6/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 8/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Muscle spasms	6.6% 9/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.1% 7/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	1.3% 1/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Psychiatric disorders Insomnia	8.8% 12/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.9% 3/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	4.5% 1/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Psychiatric disorders Anxiety	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	3.4% 1/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.6% 3/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Vascular disorders Hypertension	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	13.6% 3/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Vascular disorders Hypotension	2.9% 4/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	2.6% 2/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Tachycardia	3.6% 5/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	5.3% 4/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Angina pectoris	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	9.1% 2/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
Cardiac disorders Palpitations	0.00% 0/137 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	6.9% 2/29 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/76 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.	0.00% 0/22 • First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER